Associate Director, Data Management (Clinical)

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

ProPharma Group Life Sciences (“ProPharma Group”) focuses on providing program management and execution-based consulting within the life science industry. The Associate Director, Data Management reports to the Vice President, Data Management and Database Programming and is responsible for data management services within ProPharma Group.

Essential Functions Include:

• Coordinate and manage the work of the assigned Data Management team
• Assist in resource planning, staff training, and direct reports’ performance reviews.
• Develop strategies and support Data Management team to drive programs according to agreed timelines; if changes are proposed to agreed milestones and timelines, to assist Data Management personnel in evaluating the risk of these decisions and developing plans to minimize/mitigate these risks.
• Accountable customer satisfaction and Key Performance Indicators related to Data Management deliverables.
• Attend capability and defense presentations with clients to support the development of new business.
• Attend RFI/RFP proposal strategy meetings and operationally lead strategy development and approve client proposals and budgets.
• Work closely with Quality Assurance to ensure quality and continuous process improvement throughout the clinical and medical operations departments.
• Acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables.
• May act as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups.
• Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement, relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
• Provides project specific training to internal and external audiences as required
• Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance group as needed.
• Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management.
• Plans, manages, and requests resources for assigned projects.
• Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
• Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
• Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
• Trains and mentors’ data management staff, acts as a subject matter expert.
• Prepares input for and participates in proposal bid defense meetings.
• Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
• Maintains knowledge of regulatory guidelines and industry standards as applicable to clinical studies with specific emphasis on data management activities.
• Provides input and maintains ProPharma Group SOPs as relevant to all data management activities.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 25%).

Qualified candidates must have:

• Bachelor’s degree, Master’s degree preferred, in scientific field, data sciences preferred or the equivalent in years of experience.
• Minimum of 12 years of Clinical Data Management experience, 6 years acting as a lead data manager, and 1 year managing direct reports required.
• Strong project management skills and technical aptitude.
• Experience in Contract Research Organization (CRO) or pharmaceutical/biotechnology company preferred.
• Experience in the design and implementation of technical data management systems targeted at supporting large-scale multiple site clinical trials including supervisory experience.
• Ability to serve in a leadership role in Data Management including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Ability to handle multiple tasks to meet deadlines in a high stress environment.
• Ability to implement, control and understand productivity measures with a good understanding of financials.
• Basic computer skills in Word, Excel, and email. Industry standard system experience preferred.
• Expertise with EDC systems, such as Medidata Rave, InForm, IBM Clinical, Veeva EDC or Medrio.

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***