Study Start Up Manager

AstraZeneca

5d • $120,355 - $180,523

About The Position

In this role, you will accelerate site activations, shape regulatory and ethics submissions, and set trials up for success so our medicines reach patients sooner. You will join a nimble, outcome-driven team that sits close to decision-making. Working across clinical operations, sites, and strategy, you will remove obstacles, compress timelines, and influence how our data are positioned for the strongest possible approvals. How would you orchestrate complex submissions and negotiations to take weeks off activation timelines?

Requirements

• Bachelors Degree and a minimum of 3+ years of current/recent Clinical Study Start Up Lead work (must be full time, not a partial 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
• Minimum 3+ years of informed consent review and language negotiation with sites
• Strong verbal and written communication skills
• Strong organization and project management skills
• Bachelor’s Degree; higher degree preferred
• Excellent understanding of 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
• Good vendor management skills
• Strong organizational skills with proven ability to handle multiple projects
• Excellent communication, presentation, and interpersonal skills
• Quality-driven in all managed activities
• Strong negotiating skills
• Strong problem-solving skills

Nice To Haves

• 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

Responsibilities

• 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.
• 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.
• Prepare, review, track, and manage site and country regulatory documentation; maintain, review, and report on site performance metrics to keep delivery on course.
• Lead timely, high-quality submissions to Regulatory Authorities and IEC/IRB during the start-up period, enabling the best pathway to approval.
• Contribute to clinical and operational feasibility assessments, ensuring proposed studies are practical, high-quality, and ready to mobilize.
• Partner closely with CRAs and the Local Study Team/Local Study Associate Director to achieve start-up milestones efficiently.
• Update CTMS and related systems with accurate site data within required timelines to drive transparent decision-making.
• 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.
• Proactively follow up on outstanding actions with sites; provide regular updates to line managers on milestones, risks, and mitigations during start-up.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior