Associate Director, Clinical Data Management

Cambridge, US; Gaithersburg, US; New Jersey, US   |   full time   |   Job ID: 9879 

 

 

The Associate Director Clinical Data Management provides solid core and comprehensive data management expertise to provide high quality data management deliverables on clinical studies within his/her portfolio/platform program(s). He/She is responsible for leading the Clinical Data Management Teams and overlooking the execution of clinical trials, with regard to operational and administrative aspects. This includes day-to-day people management, resource planning, hiring and allocation of Data Management resources to the respective clinical portfolio/platform program(s). The ADCDM is working closely with the (Senior) Director Clinical Data Management to develop forward strategies and processes.

 

Key Responsibilities

 

• Organizes and conducts team meetings.
• Takes care of team development, identification of high-performance team members and working on team development together with the (Senior) Director Clinical Data Management
• Provides guidance to project teams on the oversight and supervision of CRO/third party vendors and organizes trainings as needed. Acts as a mentor for new incomers or may delegate to appropriate team member this activity. Provides continuous feedback to develop team members.
• Contributes to the development and review of portfolio documents (includes contracts, guidelines, budgets, metrics, KPIs..)
• Complies with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
• Identifies the needs of new technology or tools for Data Management and takes active role during  development and implementation.
• Supervises clinical data management activities within his/her portfolio/platform program and ensures it is per BioNTech standards and strategy.
• Escalates unresolved data or compliance issues to the functional manager(s).
• Provides guidance to Subject Matter Experts with regard to standard process developments
• Ensures the trials processes are aligned within his/her portfolio/platform program(s) and escalates any deviations or foreseen non-compliance.
• Provides expert support to the Clinical Development Team, on study design issues for BioNTech development projects and portfolio/platform program(s).
• Represents his portfolio/platform program(s) team among other department leads and functions, and supports cross-functional interactions and problem solving.
• Participates in strategic vendor selection processes for Clinical Data Management, and actively participate in vendor relationship management, includes escalation.
• Provides input on developing, revising, and maintaining core operating procedures and templates.
• Provides support or assist Quality assurance department in conducting audits involving data management activities

 

What you have to offer

 

Minimum qualifications: -

• Natural/ life sciences or scientific background (university degree) or former experience in a CRO/ biotechnology/ pharmaceutical company in a Clinical Data Management position

 

Professional Experience: -

• Minimum 12 years of experience in Clinical Data Management with wide practice in oversight of DM activities as a Lead and DM project management
• Profound knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects and experience with Clinical Database Systems and processes
• Experience with Clinical Database Systems and processes
• Experience in leading teams and resource planning

 

Skills and/or Knowledge: -

• Very good English (written and spoken)
• Effective communicative skills, active listener
• Excellent organizational skills
• Able to motivate and lead a team/ used to work in a team
• Able to work under stressful conditions
• Ready to take over responsibilities
• Able to recognize problems and provide solutions
• Detail oriented
• Experience in usual software (Word, Excel, Power Point)
• Experience with at least one Clinical Data Management System (Medidata, OCRDC, Inform, …)
• Independent and pro-active way of working

 

 

Expected Pay Range: $175,250/year to $201,500/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

 

Your Benefits:

 

BioNTech is committed to the wellbeing of our team members and offer