Site Start-up & Study Contract Manager

Are you ready to convert sharp negotiation and system mastery into faster cell therapy site activations that bring novel therapies to patients sooner? This role puts you at the center of study launch—aligning budgets, legal terms, and data flows to deliver operational clarity and speed.

You will be the connective force linking Legal, Clinical Operations, and trial sites, orchestrating everything from initial site identification and contract execution through to audit-ready documentation and operational reporting. With a deep and diverse cell therapy portfolio, your work will directly influence first-patient-in timelines, financial integrity, and the quality of our study execution. 

How will you apply your expertise to accelerate study readiness while safeguarding compliance and value?

Accountabilities:

• Contract Strategy and Budget Negotiation: Lead site budget development using FMV, historical benchmarks, and standard-of-care analysis to optimize cost and accelerate signature, ensuring responsible financial stewardship.

• Legal Partnering and Agreement Execution: Serve as the primary interface with Legal to customize and execute CSAs, MSAs, and CDAs; negotiate informed consent language and financial obligations to uphold ethical and compliant practices.

• Site Start-up Leadership: Drive site activation performance by managing timelines and dependencies, engaging proactively to meet SIV dates and compress time to first-patient-in.

• Document and Template Stewardship: Oversee creation, version control, and consistency of study documents; manage timely upload of regulatory materials to the Global Electronic Library to ensure visibility and standardization.

• TMF and Audit Readiness: Ensure complete, accurate capture of all contract and study-related documents in the TMF and contracting systems to maintain inspection readiness and data integrity.

• Tools and Reporting Ownership: Act as a technical owner for study delivery tools; develop dashboards and trackers for materials, equipment, and administrative tasks to provide real-time transparency and drive decisions.

• Data and Systems Interface: Partner with Data Management Centers to enable seamless flow of study documents and clinical-regulatory data across systems, reducing friction and cycle time.

• Process Innovation and SME Leadership: Identify gaps in study delivery methods; design and embed practical improvements that enhance business continuity and regulatory compliance; mentor teams to scale best practices.

Essential Skills/Experience:

• Education: Bachelor’s degree in a relevant Life Sciences, Legal, or Business discipline.

• Industry Experience: Proven experience in Study Management and Contract Negotiation within a pharmaceutical, CRO, or clinical background.

• Technical Proficiency: Advanced knowledge of ICH/GCP guidelines, clinical-regulatory requirements, and electronic document management systems (e.g., Veeva Vault, CTMS).

• Negotiation & Influence: Strong ability to influence internal stakeholders and external institutions to secure favorable contract terms and meet project milestones.

Desirable Skills/Experience:

• Advanced degree (MSc, PhD, or JD) or professional clinical research certification (CCRP, PMP).

• Specific expertise in cell therapy study delivery.

• Experience with automated payment schedules and financial forecasting within clinical trials.

Join a team where science drives every decision and your operational impact is felt by patients worldwide. You will collaborate with experts across disciplines—imagine clinical contracts specialists, biomarker scientists, trial physicians, and data modelers solving hard problems side by side—to shape how innovative trials are designed and launched. With one of the industry’s most ambitious oncology pipelines, you’ll leverage cutting-edge approaches, from novel endpoints to AI-enabled insights, while working in a culture that values courage, learning, and kindness as much as results. Your contribution will shorten the path from discovery to treatment and help redefine what’s possible in cancer care.

Step into this role to accelerate study start-up, elevate contract value, and bring transformative oncology medicines to patients faster—make your move today!

Date Posted

14-mai.-2026

Closing Date

24-mai.-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.