Study Start Up Manager

Job description

Are you ready to lead country-level study start-up that turns bold science into real treatments faster? 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? Accountabilities: - 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 to keep delivery on course. - Authority and Ethics Submissions: Lead timely, high-quality submissions to Regulatory Authorities and IEC/IRB during the start-up period, enabling the best pathway to approval. - 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 Skills/Experience: - 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 - This is a lead start up position; 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 Desirable Skills/Experience: - 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 in the same room to unlock faster decisions. We balance bold ambition with genuine support, valuing kindness alongside drive, and encourage you to question, experiment, and harness new tools that shorten development cycles and amplify patient impact. Step into a role where your expertise activates studies faster and strengthens approvals—bring your start-up leadership to AstraZeneca and create momentum that matters now! Benefits We offer a competitive Total Reward program, including: · Competitive base salary, annual bonus, and long-term incentives · Generous paid time off program · Comprehensive benefits package Diversity and Inclusion at AstraZeneca AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive team that represents a diverse group of backgrounds and perspectives, knowing that inclusion drives better outcomes.We welcome all qualified candidates and align with applicable laws regarding inclusivity and employment eligibility. Individuals with disabilities can request reasonable accommodations during the application or interview process, as well as for essential job functions. The annual base pay (or hourly rate of compensation) for this position ranges from $120,355.20 - $180,522.80 USD Annual , either as annual base pay or as the hourly rate (annual base pay divided by 2080 hours)]. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted 25-Aug-2026 Closing Date 12-Sep-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.