Experienced Director of Clinical Data Management, RTP Pharma – Top $$

Job Type: 
Data Management, Biostatistics and Programming
Employment Category: 
Direct Hire

Our client, an RTP area pharmaceutical firm in high growth mode, is actively recruiting for an exceedingly competent Data Management leader to drive all clinical data management activities.  This company is building.  Right candidate will complement broad and deep knowledge of data management practices and standards, with exceptional operational savvy and personal leadership skill.  Company will pay absolute top dollar to attract and retain a star.

Key things to note:

  • This company has several marketed products and a rich and expanding pipeline.  Data Management demands are increasingly complex and voluminous.  Seek candidate who brings the knowledge and experience to optimize CDM strategies, tools and tactics.  Up-to-date knowledge of database and technology Best Practices will be critical.
  • This Director will oversee the work of a small team as well as CROs and other outside vendors/consultants.  Seek a seasoned supervisor of people and process.
  • This Director will collaborate with numerous other departments and stakeholders and, at times, drive the work of cross-functional teams. Seek a natural leader who is also a willing team-player.
  • This company is in building mode.  Seek a hands-on Director who will drive the strategic, challenging aspects of the role while pitching in on the more mundane, but essential, clerical aspects of clinical data management.

This Director will lead clinical data management activities including the department’s overall strategy, management of day-to-day operations, oversight of vendors, standards development and implementation, FDA compliance and future growth.

Specific responsibilities:

  • Coordinate activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to data collection, review, and reporting.
  • Define and document the data quality review strategy for clinical trials in collaboration with various stakeholders (e.g. statistics, medical, safety, development, clinical operations, etc.).
  • Lead the development and application of optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution. 
    • Ensure data collection systems are used to full extent possible to support ongoing reviews of data and study operations.
    • Leverage electronic systems in new and innovative ways.
    • Lead database design to ensure high quality and integratable datasets and inspection readiness at all times.
    • Participate in continuous improvement activities, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, ad-hoc analysis and end-to-end data standards.
  • Lead a small internal team. 
  • Create policies, SOPs and facilitate training initiatives for data management.
  • Create or review data management plans and data transfer agreements. 
  • Provide a strategy for conducting interim and final database lock.
  • Oversee study level data management team or individuals functioning in this role. Depending on resources, may be called on to manage individual studies as well. 
  • Lead activities with external vendors to develop systems/applications for clinical trial data collection (e.g. design of eCRF system, ePRO/eCOA collection, agreement of format, etc.) to ensure quality, efficiency, and timely deployment.
  • Ensure effective quality oversight and management of external partners (e.g. eCRF providers, CROs, etc.) performing data management services.  Lead external audit effort.
  • Support clinical study report creation with input on data quality and collection as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.

Targeted candidate will offer a related degree (advanced degree preferred) and 10+ years of directly-related industry experience, demonstrating high degree of knowledge of and competence with all clinical data management functions noted above.  Global, sponsor experience strongly preferred.

Other priorities include:

  • Strong knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and their capabilities 
  • Well-versed in industry trends and emerging technologies supporting data collection
  • Understanding of database and dictionary structures (e.g. MedDRA, WHODrug) and CDASH standards
  • Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.  Experience with JMP Clinical or similar review tool (J-Review, Spotfire, etc)
  • Familiarity with the entire drug development process, ideally in a global arena. Experience with regulatory submissions (NDA, MAA, etc) is strongly preferred.

Further, we seek a candidate with tremendous personal leadership; someone who brings a strategic vision as well as the operational savvy to successfully execute; someone who can readily gain the respect and cooperation of colleagues, partners, vendors and staff; someone who knows how to engage, guide and manage others to enable them to optimize their performance, growth and contribution.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates targeted at this time.