Associate Director, Clinical Data Management

at  TSP A Syneos Health Company

PREFERRED EDUCATION

• Bachelor’s degree in science or related area (or equivalent); Masters or Advanced Degree preferred.

PREFERRED EXPERIENCE

• 5+ years of experience in clinical data management experience in the biotech/ pharma industry; significant end-to-end, hands-on experience in all aspects of data management.
• Experience with phase global phase III clinical trials for a biotechnology company, preferably with Vaccines.
• Experience in Industry Standards (e.g., CDISC) in the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
• Experience with Medidata Rave (EDC) and Metadata Repository (MDR) is preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Ability to communicate technical concepts clearly and concisely to non-technical colleagues.
• Strong organizational skills, attention to detail, and self-motivated.
• Vendor management experience.
• Experience in creating all components of a submission package.
• Team player, with the ability to work successfully across functions.

EQUAL OPPORTUNITY EMPLOYER/PROTECTED VETERANS/INDIVIDUALS WITH DISABILITIES

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

PURPOSE

The Associate Director, Clinical Data Management will lead Data Management for multiple clinical studies and/or a clinical development program. Reporting to the Senior Director, Clinical Operations, the incumbent will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout and be responsible for the oversight and management of clinical data management activities outsourced to CROs.

KEY ROLES AND RESPONSIBILITIES

• Responsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to the scope of work and service agreements.
• Develop Data Management metrics and key performance indicators to aid in the oversight and management of CRO partners.
• Responsible for CRO adherence to project timelines, from study startup through study closeout, ensuring high quality and integrity of all deliverables.
• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
• Review data via listings and visualization tools to report on performance and quality; review will be performed with clinical data within studies and across multiple studies for trend analysis.
• Contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs.
• Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
• Participate in vendor qualifications and audits.
• Oversee the planning, execution, and maintenance of major projects and initiatives, if required.
• Lead data management study inspection readiness activities and support of submission activities as needed.
• Train and mentor DM staff or members of the clinical trial team on processes, projects, systems, and programs.
• Perform hands-on data management responsibilities, if required.