Senior Manager, Clinical Data Management, Study Lead

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Data Management, Study Lead based in the United States.** Lead clinical data management activities across multiple clinical trials, ensuring the accuracy, integrity, quality, and timely delivery of critical study data. In this senior role, you will oversee the full data management lifecycle, from study start-up through database lock and archiving, while serving as a key partner to clinical study teams, contract research organizations (CROs), and external data vendors. You will provide strategic oversight, identify and resolve data quality issues, and ensure compliance with applicable regulatory requirements and industry standards. Working in a collaborative, science-driven environment, you will help advance clinical research through robust data practices and continuous process improvement. You will also lead, mentor, and develop data management professionals while promoting accountability, operational excellence, and effective cross-functional collaboration. This opportunity combines hands-on study leadership with people management and the chance to contribute to clinical programs that aim to improve patient outcomes. ### Accountabilities - Serve as the clinical data management study lead and primary point of contact for clinical study teams, CROs, and external data vendors across multiple trials. - Oversee clinical data management activities throughout the study lifecycle, from start-up and planning through database lock and final data archiving. - Provide sponsor oversight of CRO data management activities, evaluating deliverables, identifying gaps, and ensuring issues are addressed promptly. - Review and approve essential study documentation, including data management plans, case report form (CRF) designs, and data transfer specifications. - Ensure study documentation remains inspection-ready and that electronic Trial Master File (eTMF) records meet applicable documentation standards and quarterly compliance review requirements. - Monitor data quality, project timelines, deliverables, and operational risks, proactively escalating concerns and driving resolution. - Lead, coach, and develop clinical data management team members, including supporting recruitment, performance management, and professional growth. - Collaborate with cross-functional stakeholders to coordinate study deliverables, resolve data management challenges, and maintain alignment across clinical programs. - Identify opportunities to improve data management processes, operational efficiency, and consistency across studies. - Lead cross-functional initiatives and serve as a subject matter expert, providing guidance, knowledge sharing, and training on clinical data management practices. - Ensure data management activities adhere to applicable regulations, clinical research standards, and internal quality requirements. ## Requirements - Bachelor's degree in Mathematics, Science, or a related field. - At least eight years of clinical data management experience within the biotechnology, pharmaceutical, healthcare, or related industries. - Demonstrated experience leading clinical studies and study teams in a data processing or clinical data management environment. - Strong knowledge of applicable regulatory requirements and industry standards, including 21 CFR Part 11, International Council for Harmonisation Good Clinical Practice (ICH-GCP), and Clinical Data Interchange Standards Consortium (CDISC) standards. - Experience overseeing CROs and external data vendors, reviewing study documentation, monitoring deliverables, and resolving data quality or compliance issues. - Strong understanding of clinical data management processes across the study lifecycle, including study start-up, data collection, quality oversight, database lock, and archiving. - Excellent problem-solving, project management, organizational, and analytical skills. - Strong written and verbal communication skills, with the ability to influence stakeholders and coordinate virtual teams in a matrixed environment. - Demonstrated ability to manage competing priorities, identify risks, and drive issues to resolution while maintaining study quality and timelines. - At least three years of people management experience is preferred. - Certified Clinical Data Manager (CCDM) certification is preferred. - Ability to work effectively across cross-functional teams and support continuous improvement in a regulated clinical research environment. ## Benefits - **Annual salary range:** $134,400–$219,200, with final compensation determined by factors such as role level, location, qualifications, skills, and experience. - Competitive total rewards package, which may include annual bonuses or other incentive plans and equity awards, depending on eligibility. - Retirement benefits, including a 401(k) plan with company matching, where applicable. - Health and wellness programs. - Medical, dental, and vision insurance, as well as life and disability insurance, depending on eligibility. - Paid time off and family support benefits. - Pension or other retirement benefits where applicable. - Remote work arrangement as listed for this position; candidates should confirm any specific on-site expectations with the recruiting team. - Opportunities for professional development, subject matter expertise, and leadership growth within a collaborative clinical research environment. - Benefits and incentive eligibility may vary based on employment location, role, and applicable company policies.