Study Start Up Manager

About the role

Lead country‑level study start‑up that turns bold science into real treatments faster. You will accelerate site activations, shape regulatory and ethics submissions, and set trials up for success so medicines reach patients sooner. Working across clinical operations, sites, and strategy, you will remove obstacles, compress timelines, and influence how data are positioned for the strongest possible approvals.

Responsibilities

• Country‑Level Start‑Up Leadership: Own all start‑up activities at the country level, ensuring compliance with company procedures, ICH‑GCP, and local regulations while driving to target activation dates.
• Site Primary Contact: Serve as the main point of contact for sites during start‑up, leading informed consent reviews and language negotiations to resolve issues quickly and build trust.
• Regulatory Documentation: Prepare, review, track, and manage site and country regulatory documentation; maintain, review, and report on site performance metrics.
• Authority and Ethics Submissions: Lead timely, high‑quality submissions to Regulatory Authorities and IEC/IRB during the start‑up period.
• Feasibility and Planning: Contribute to clinical and operational feasibility assessments, ensuring proposed studies are practical, high‑quality, and ready to mobilize.
• Cross‑Functional Collaboration: Partner closely with CRAs and the Local Study Team/Local Study Associate Director to achieve start‑up milestones efficiently.
• Systems and Data Integrity: Update CTMS and related systems with accurate site data within required timelines to drive transparent decision‑making.
• eTMF Quality and Readiness: Ensure timely collection and upload of essential documents into the eTMF; support QC checks to verify completeness and correctness before sites are set ready to enroll.
• Risk and Performance Management: Proactively follow up on outstanding actions with sites; provide regular updates to line managers on milestones, risks, and mitigations during start‑up.

Essential Requirements

• Bachelor’s degree (higher degree preferred) and a minimum of 3+ years of current/recent Clinical Study Start‑Up Lead experience (full‑time, not a mix of maintenance or close‑out).
• Minimum 1+ year of current/recent hands‑on Veeva Vault experience.
• Proven expertise leading and driving all aspects of start‑up and serving as the main point of contact to sites.
• 3+ years of informed consent review and language negotiation with sites.
• Strong verbal and written communication skills.
• Strong organization and project‑management skills.
• Excellent understanding of the clinical trial process across Phases II–IV and ICH‑GCP.
• Good understanding of clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start‑up processes.
• Project‑management experience in a fast‑paced environment.
• Vendor‑management skills.
• Quality‑driven in all managed activities.
• Strong negotiating, problem‑solving, presentation, and interpersonal skills.

Desirable Requirements

• Experience leading multi‑center, multi‑country start‑up across diverse therapeutic areas.
• Direct interaction with ethics committees and health authorities beyond submissions, including addressing queries.
• Familiarity with broader eClinical ecosystems (eTMF, CTMS, eISF) and process automation.
• Proficiency in additional languages to support site negotiations and document localization.
• Demonstrated ability to design start‑up playbooks, KPIs, and continuous‑improvement initiatives.

Why AstraZeneca

Here, your start‑up leadership shapes the path from promising data to approved medicines. You will work on assets at different stages, influence strategy early, and collaborate with experts who bring science, operations, and technology together to unlock faster decisions. AstraZeneca balances bold ambition with genuine support, valuing kindness alongside drive, and encourages you to question, experiment, and harness new tools that shorten development cycles and amplify patient impact.

Benefits

• Competitive base salary, annual bonus, and long‑term incentives
• Generous paid time off program
• Comprehensive benefits package, including medical, prescription drug, dental, and vision coverage
• Qualified retirement program (401(k) plan)
• Paid vacation, holidays, and leaves

Pay

The annual base pay for this position ranges from $120,355.20 to $180,522.80 USD (or equivalent hourly rate). Base pay may vary based on market location, job‑related knowledge, skills, and experience. Additional compensation includes a short‑term incentive bonus, eligibility for an equity‑based long‑term incentive program (for salaried roles), retirement contributions, and commission eligibility where applicable.