The Role: Reporting to the Head of Biometrics, the Director, Clinical Data Management will oversee the Clinical Research Organization (CRO) responsible for clinical data management (CDM) activities on one or more late-phase clinical trials, from study start-up through database lock and close-out. This role requires strong communication skills and the ability to navigate effectively across a matrixed organization, partnering with cross-functional stakeholders to establish data management standards and processes while applying strong problem-solving skills. The Director will also contribute to team building, and mentor contractors and/or junior team members, serving as subject matter expert in all areas of CDM processes and technology. This role is required to be onsite in Burlington office 3 days a week.
Here's What You'll Do: - Provide data management subject matter expertise to project team members during all phases of a trial's life cycle,
- Assume biometrics project lead responsibilities for assigned trial(s), ensuring the successful integration and oversight of biometrics team(s) on the trial(s), including oversight of external biometrics vendors, and ensuring the quality and timeliness of deliverables, and alignment with trial objectives and budget.
- Oversee the CRO and other external data vendors (e.g., central laboratory, ePRO/eCOA, IRT) responsible for CDM activities, including eCRF design, data validation, query management, and database development.
- Lead and coordinate internal cross functional review of and input to data management deliverables such as eCRF, eCCGs, EDC User Acceptance Testing, and related operational specifications, manuals and guidelines
- Ensure data management activities are conducted in accordance with GCP, GCDMP, internal SOPs, and meet all regulatory requirements
- Support resource planning, budget forecasting, timelines, and issue resolution for ongoing trials
- Partner cross-functionally across the matrix to establish data management standards and processes, applying strong problem-solving skills as needed
- Identify opportunities to improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output. Evaluate biometrics tools to efficiently and effectively meet trial needs.
- Develop and maintain study-level Data Management Plans (DMPs) and oversee medical coding conventions (e.g., MedDRA, WHO Drug Dictionary)
- Build and maintain data management SOPs, contribute to team-building initiatives, and provide mentorship and guidance to contractors and junior team members
Here's What We'll Bring to the Table: - Highly competitive package with healthcare coverage including medical, dental and vision
- Fully funded Healthcare Savings Account for high-deductible PPO Plan
- 4 weeks paid time off annually
- 10 company paid holidays and year-end shut down
- 401k (traditional and Roth offered) with company match
- A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability
- Flexible spending accounts for medical and dependent care expenses
Expected Pay Range: $220,000-$235,000
Our Mission:
Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.
Requirements
Here's What You'll Bring to the Table: - Bachelor's degree required, Master's degree is a plus
- At least 10 years of data management experience in a clinical trial industry, biotechnology and/or pharmaceutical experience, with at least 2 years of matrix management experience.
- Experience managing Data Management CROs
- Experience running phase II/III clinical trials, with demonstrated ability to work cross functionally and collaboratively with teams to deliver high quality data within timelines & budget
- Demonstrated ability to manage multiple concurrent clinical trials and competing priorities in a fast-paced, resource-lean biotech environment
- In-depth understanding of drug development and study conduct processes through to the electronic submission of clinical data, overall Biometrics processes from Protocol to Clinical Study Report, industry-standard data dictionaries & questionnaires/clinical outcome assessments, and regulations related to and affecting clinical data management including but not limited to GCP, ICH guidelines, EU directives, 21CFR Part 11, Good Clinical Data Management Practices (GCDMP)
- Experience with CDISC (CDASH and SDTM)
- Hands-on experience working with mainstream EDC systems, preferably Rave
- Familiarity with Data Visualization Tools for quick customized data access (e.g. Spotfire, Tableau or other commercially available platforms)
- Expertise with Cardiovascular clinical trials is a plus
- Experience developing and implementing CDM standards
- Strong executive presence, focus and drive to succeed, confidence, passion, and high energy. Excellent leadership skills with the ability to inspire, lead, manage, collaborate, and motivate others in a multi-functional matrix environment.
- Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively.
