Associate Director Study Data Manager
About The Position
Associate Director Study Data Manager Introduction to role: Are you ready to lead clinical data delivery that accelerates breakthrough medicines for patients with cancer? Step into a role where your judgment and leadership directly shape the speed, integrity, and readiness of pivotal trials. You will be the study-level data authority, aligning vendors, standards, and systems to deliver complete, inspection-ready datasets that inform go/no-go decisions and regulatory submissions. Working at the heart of a fast-moving portfolio, you will influence how data are captured, cleaned, and curated across multiple indications, ensuring quality that stands up to scrutiny. How will you apply your vendor leadership and data standards expertise to bring precision to every decision? This is a hybrid position, with a requirement to work three days in the office.
Requirements
- University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
- Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
- Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies.
- Demonstrated ability to work effectively with external partners.
- Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
- Demonstrate understanding and experience in query management process and reconciliation activities.
- Good communication and interpersonal skills including effective problem solving.
- Ability to work independently without close supervision.
- Excellent written and verbal communication skills.
- Ability to work in a global team environment.
- Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.
Nice To Haves
- Demonstrated knowledge of clinical and pharmaceutical drug development process.
- State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.
- Experience within Sponsor organization and Regulatory inspections.
Responsibilities
- Take end-to-end accountability for Clinical Data Management deliverables on assigned studies, serving as the first line of contact and orchestrating plans, timelines, and quality outcomes.
- Act as primary point of contact for the DM vendor; guide and supervise the Lead Data Manager/DM Team Lead (CRO or in-house) to meet scope, timelines, and quality. Review delivery against KPIs, oversee billing accuracy, and recommend invoice payments.
- Provide expert oversight of day-to-day data operations, ensuring proactive issue identification, robust mitigation with vendors, and timely escalation. Drive adherence to standards and processes to achieve consistent, high-quality data capture.
- Contribute to corporate, therapeutic, and program-level data capture standards; champion adoption to improve consistency and downstream analysis readiness.
- Lead DM inspection preparation at the study level, provide input into regulatory inspections and audits, and ensure compliance with Trial Master File requirements.
- Provide input to the selection and use of software systems, devices, and vendors as needed; bring practical insight to database build, EDC configuration, and interoperability considerations.
- Maintain awareness of internal and external trends; participate in change initiatives and continuous improvement activities to evolve DM operating models and ways of working.
- Oversee vendor timelines and milestone deliverables; manage budget adherence and performance metrics to enable predictable, high-quality delivery.
- Mentor junior Clinical Data Management colleagues, building capability and strengthening delivery across studies.
Benefits
- short-term incentive bonus opportunity
- equity-based long-term incentive program
- retirement contribution
- commission payment eligibility
- competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- annual Personal Days
- Contract Benefits Program
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Associate degree
