Overview
Description
Site Contracts Lead with Global experience
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with. When we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Job Summary:
Manages negotiation of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract negotiators for Site Contracts Service Center for awarded projects. Ensures global CTA negotiation comply with sponsor and Company requirements. Identifies project and/or Company level investigator budget related problems, and works with internal and external team members to provide and implement solutions. Establishes strong working relationships with customers and internal project teams. Supports global operational initiatives at the project, Sponsor or relationship level. May serve as strategic point of contact for internal and external customers to meet site contracting/budgeting goals.
Core Responsibilities
Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.
Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.
Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.
Plans contract execution strategy for assigned studies—including forecast of site-specific contractual execution timelines with as much accuracy as possible—and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.
Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.
Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets.
Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.
Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.
Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.
Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.
May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Minimum Qualifications
BS degree in life sciences, a health related field, or equivalent combination of education and experience.
Preferred experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.
Thorough knowledge of applicable regulations, drug development and clinical project management procedures.
Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet.
Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
Attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor team members.
Preferred Qualifications
6+ years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment, including ownership of multi-country studies.
Demonstrated expertise negotiating site CTAs and investigator budgets, including direct interaction with sites, sponsors, Site Contract Service Centers, and Legal teams.
Strong experience drafting and managing site-specific CTAs from country or global templates and ensuring alignment with sponsor MSAs and country requirements.
Proven ability to manage contract amendments and protocol-driven changes, maintaining compliance with timelines, quality standards, and documentation requirements.
Experience serving as an escalation point for complex contract, budget, or process issues, with a track record of proactive risk identification and resolution.
Hands-on experience with SSU tracking systems and contract repositories, including real-time milestone tracking and metadata management.
Demonstrated leadership in training and mentoring junior staff, including contribution to SOPs, WIs, templates, and internal training materials.
Experience supporting business development activities, such as proposal development, bid defenses, or sponsor-facing meetings.
Salary Range
$67,700– $115,100
Location
Open to US-Remote candidates.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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A leading biopharmaceutical solutions organization in Toronto is seeking a Sr Principal / Principal Medical Writer to drive the completion of complex writing deliverables and ensure compliance with regulatory standards. You will mentor less experienced writers and interact with clients to produce high-quality documents. The role offers a salary range of $95,000 to $175,700 along with comprehensive benefits including health and retirement plans. #J-18808-Ljbffr
A leading life sciences services organization is seeking a Site Contracts Lead to manage the negotiation of clinical study agreements. The ideal candidate will have expertise in contract negotiation, strong interpersonal skills, and the ability to oversee processes across global teams. Responsibilities include ensuring compliance with regulations, establishing relationships with internal and external stakeholders, and managing the execution strategy as part of a dynamic and dedicated team. Competitive salary and benefits offered. #J-18808-Ljbffr
Elevate your career as a Senior Medical Writer, leading and coordinating significant medical writing deliverables. This remote role requires expertise in complex documentation and regulatory standards to achieve quality outcomes.
In this senior position, you'll oversee the completion of diverse medical writing tasks, including protocols, reports, and presentations. Key skills include managing document strategies and ensuring adherence to regulatory guidelines. This role demands effective collaboration with internal teams and external clients, driving project success with minimal supervision.
Key Responsibilities:
• Lead completion of medical writing deliverables
• Manage clinical documentation strategy and execution
• Coordinate quality reviews and editorial processes
• Advise clients on data presentation strategies
• Mentor junior medical writers with complex projects
Requirements:
• Experience in medical writing with strong publication skills
• Familiarity with regulatory standards and ICH guidelines
• Excellent communication and mentoring abilities
• Background in biopharmaceutical processes preferred
• Strong attention to detail in documentation
Leverage your expertise in medical writing to drive successful outcomes and establish impactful publication strategies while collaborating with diverse teams.
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Lead the negotiation of clinical study agreements as a Site Contracts Lead. Ensure seamless contract execution and compliance across global project teams in a dynamic environment.
In this role, you will manage the intricacies of clinical study agreements (CTAs) and drive effective negotiation strategies. You will collaborate closely with regulators, internal teams, and sponsors to resolve challenges related to investigator budgets. Your leadership will guide the overall strategy for successful contract execution within assigned studies.
Key Responsibilities:
• Oversee execution of clinical study agreements (CTAs)
• Manage escalation of contractual challenges efficiently
• Advise stakeholders on contract elements and issues
• Ensure alignment of contract strategies with project timelines
• Maintain documentation status reports and deadlines
Requirements:
• Bachelor’s degree in life sciences or relevant field
• 6+ years experience in clinical trial negotiations
• Strong understanding of contract management processes
• Excellent organizational and communication skills
• Ability to prioritize tasks in fast-paced environments
Utilize your vast knowledge in site contracts to streamline clinical trial processes, fostering effective partnerships and ensuring compliance for impactful research.
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Associate Director/Director Strategy, Real World Evidence and Late Phase
Benefits
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Act as a SME in RW study design and strategy across Syneos Health
Develop innovative Real World Data (RWD)-based solutions
Enhance growth, identify opportunities, and drive sales for the RWLP Business Unit.
Work with current and potential clients to identify their RWE needs and serve as liaison between sponsor and internal Syneos teams.
Work closely with RWLP operations teams to determine project delivery requirements and ensure customer satisfaction post-delivery. Work closely with Business Development to identify and generate early engagement and potential sales opportunities and continuously manage sales enablement collateral,
Serve as go‑to point person both internally and externally for resolution of conflicts, setting proper expectations, escalation, etc. Document all contacts in Salesforce for tracking and metrics.
Provide accountability, preparation and leadership for customer ballparks, Request for Information (RFIs), Request for Proposals (RFPs), presentations, proposal defenses and bid defense meetings (BDMs)
Analyze department sales data and overall opportunities and present to leadership.
Coordinate the necessary medical/scientific input from outside experts/consultants/advisors.
Represent Syneos Health by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and publishing scientific or industry related articles
Participate in the development of Standard Operating Procedures (SOPs), medical/scientific tools, training, staffing requirements, etc. where required.
Identify and oversee the delivery of RWLP vendor/partner services, focusing on the development and integration of service offerings that best align with operational needs.
Contribute account‑level insights to identify and address operational risks and areas for process improvement within the RWLP Business Unit.
May travel up to 40% of the time.
Lead or actively participate in departmental, project, leadership, and other initiatives.
Qualification Requirements
BA/BS in the life sciences, nursing degree, or equivalent education or equivalent related experience, with experience in the development of scientific studies and data analysis. PhD preferred.
Strong methodologic background across various RW study designs and methods
Strong RWD background and knowledge of US and ex‑US RWD sources and their fitness for different study types
Background in senior‑level role in pharma or CRO preferred (but not required); therapeutic expertise in Oncology, Cell & Gene Therapy, Rare Disease, Genomics, or Immunology preferred
Must have spent some time actively managing clinical and RW research projects across functional areas.
Thorough knowledge of Regulatory requirements and the clinical development process
Flexibility, the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines, and deliver high quality work in a dynamic environment is essential.
Requires strong presentation, documentation, interpersonal skills, and a team‑oriented approach.
Exceptional influencing and networking skills
Must be comfortable in a customer‑facing role while also able to provide technical expertise.
Minimum of five (5) to seven (7) years of RWLP Experience in a CRO, pharmaceutical, or Biotechnology Company for Director (more experience required for Senior Director role)
Summary
JOB SUMMARY The Associate Director/Director, Real World Evidence (RWE) Strategy will serve as a Subject Matter Expert (SME) of the RWE domain and will develop Real World (RW) solutions for our clients in partnership with the Syneos Health RW and Late Phase (RWLP) operations team, Epidemiology team, and other SMEs. The primary responsibility of this role is to proactively engage with sponsors and external partners to drive new business–with the overarching goal of achieving target revenue and profitability for the LP Business Unit while exceeding customer expectations. This role is characterized by high client interaction, emphasizing the importance of cultivating strong client relationships.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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Sr Principal / Principal Medical Writer (Publication Strategy/Planning) - East Coast Preferred - Single Sponsor
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Job Responsibilities
Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
Completes a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
Adheres to established regulatory standards, including ICH E3 guidelines, as well as company SOPs, client standards, and approved templates, authorship requirements, and style/formatting guides, when completing medical writing projects, on time and on budget.
Advises clients and study teams on data presentation and production strategies to meet client objectives/expectations and maintain quality standards.
Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
Serves as expert peer reviewer for the internal team, providing review comments to maximize clarity, accuracy, and relevance.
Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Provides feedback to define statistical output requirements and document needs.
Interacts with clients and internal stakeholders to produce writing deliverables. Works with staff across the company to advance priorities.
Performs online clinical literature searches and complies with copyright requirements.
Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a technical SME and contributes to internal materials and presentations. Contributes to changes to internal processes and capabilities.
Mentors and leads less experienced medical writers on complex documents.
Develops deep expertise on key topics in the industry and regulatory requirements affecting medical writing. Engages externally with industry groups on industry initiatives.
Aware of budget specifications for assigned projects, communicates status and changes to medical writing leadership. Contributes to bid projections.
Communicates status to medical writing leadership; negotiates timelines and deliverables.
Represents the medical writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
Completes required administrative tasks within the specified timeframes.
Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
Salary and Benefits
Salary Range: $95,000.00 - $175,700.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, and proficiency for the role. Benefits may include company car or car allowance, health benefits, 401k with company match, eligibility for Employee Stock Purchase Plan, commissions/bonus eligibility, and flexible PTO/sick time. Paid sick time eligibility may vary by location in accordance with applicable laws. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Get to know Syneos Health: Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.
Additional information: Duties and responsibilities may be assigned or revised at any time. The company may consider equivalent experience, skills, and/or education. This description does not constitute a contract. The company complies with applicable disability laws and provides reasonable accommodations where appropriate.
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Director, Project Delivery (Early Phase) - Canada Based only
The Director, Project Delivery will ensure the strategic and operational success of project delivery while fostering strong client partnerships, maintaining financial health, and driving organizational growth and innovation. The role collaborates across functions to ensure projects are delivered on time, within scope, and aligned with client expectations and corporate objectives.
Job Responsibilities
Act as senior operational leader and key point of contact for assigned clients, building and sustaining long‑term partnerships.
Understand client needs and proactively identify and implement tailored solutions that add value.
Establish and maintain appropriate governance structures for client relationships, ensuring effective communication and collaboration.
Drive client satisfaction by ensuring smooth operational delivery and minimal escalation needs.
Present Syneos Health capabilities and updates during client governance meetings, enhancing the organization’s value proposition.
Lead proposal development for new opportunities, collaborating with cross‑functional teams to deliver high‑quality, competitive submissions.
Contribute to winning new business by providing strategic insights and operational expertise during bid defense meetings (BDMs).
Own the overall strategy and execution for project delivery across a portfolio of clinical research studies.
Conduct monthly risk reviews and quarterly financial assessments to ensure project health.
Drive data‑driven decision‑making by leveraging dashboards and analytics to identify risks and develop mitigation strategies.
Ensure compliance with project timelines, budgets, and quality standards.
Mentor project leaders in risk management, forecasting, and operational excellence.
Engage in assigned corporate and departmental initiatives aimed at improving project delivery and organizational efficiency.
Champion change management efforts, including system and process migrations.
May include line management responsibilities for project management staff.
Qualifications
Requires a BA/BS in life sciences, nursing degree, or equivalent education or experience, plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company (10–12 years of experience recommended).
Prior cross‑functional project management experience within the clinical trial industry is required.
Pharma/CRO experience required, including client relationship management.
Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures.
Proficiency with ICH/GCP guidelines.
Strong client relationship management and business development skills.
Proven ability to deliver complex clinical research projects on time and within budget.
Exceptional financial acumen and resource management capabilities.
Strategic thinker with excellent problem‑solving and decision‑making skills.
Effective communicator with strong negotiation and conflict resolution abilities.
Demonstrated ability to lead, mentor, and develop high‑performing teams.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. This job description is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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Drive project success by leading client partnerships as a Director. Ensure strategic alignment and operational efficiency through innovative solutions and effective project management.
This pivotal role requires cross-functional collaboration to meet client needs in a clinical research environment. You will focus on enhancing client satisfaction, maintaining project health, and mentoring project leaders. Implement governance structures and leverage analytics to inform decision-making and improve delivery processes.
Key Responsibilities:
• Build sustainable relationships with assigned clients
• Lead operational delivery and risk management strategies
• Present organizational capabilities in client meetings
• Drive proposal development for new business opportunities
• Engage in initiatives for organizational efficiency
Requirements:
• BA/BS in life sciences or related field required
• 10–12 years of relevant clinical experience
• Proven client management and business development skills
• Strong knowledge of ICH/GCP guidelines
• Demonstrated leadership and team development abilities
Shape client engagement by delivering high-quality clinical research projects on time while fostering innovation and efficiency.
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Drive advancements in healthcare as the Real World Evidence Strategy Lead. Focus on developing high-impact solutions that meet client needs while overseeing project execution and stakeholder engagement.
In this pivotal role, you will leverage your expertise in Real World Data to create effective strategies that promote business growth. Your responsibilities will include engaging with clients, managing cross-functional teams, and ensuring operational excellence in project delivery. This position is key in establishing ongoing relationships and enhancing the reputation of the RWLP Business Unit.
Key Responsibilities:
• Design and execute RWE strategies for the industry
• Enhance business development through client interactions
• Collaborate with operations teams for project delivery
• Analyze and report on department sales data
• Lead initiatives to improve process efficiencies
Requirements:
• BA/BS in life sciences; PhD is a plus
• Minimum of five years in RWLP roles
• Strong presentation and networking abilities
• Proven experience in managing complex projects
• Ability to provide technical insights in client-facing situations
Utilize your RWE expertise to foster relationships and achieve strategic success in the ever-evolving healthcare landscape.
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