Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – firstname.lastname@example.org
- The Clinical Data Management Lead will work as part of a multidisciplinary team, providing leadership of clinical data management activities across multiple programs and provide data science solutions in support of company sponsored studies.
- The Clinical Data Management Lead will provide effective quality oversight and management of external partners (e.g., CROs, specialty labs, technology providers, etc.), as well as external study partner data management teams, to ensure complete, high-quality, and reliable data and timely delivery according to quality standards and requirements from study start-up through completion.
- The successful candidate will have demonstrated expertise with industry-leading eCRF tools, well-versed on industry trends to optimize collection, integration, monitoring, review of data, and the necessary organizational skills to provide close oversight of external partners.
- The Clinical Data Management Lead will also be expected to establish highly collaborative and fruitful partnerships with internal and external study managers, statisticians, programmers, analysts and clinical staff with the purpose of gathering data collection requirements and data review needs that ensure high quality clinical data to support the statistical analysis and reporting of all sponsored studies.
- This role will be expected to implement quality plans in collaboration with internal stakeholders that define the review strategy for each clinical trial and develop/execute/review project documentation including but not limited to data management plans, database builds, eCRF Completion Guidelines, Edit Checks, Query Logic, UAT, and work instructions for assigned projects.
- The ideal candidate will also have sufficient experience in continuous improvement initiatives to build and deliver end-to-end data standards, universal and consistent application, and standard operating procedures to the company clinical data management strategy.
Qualifications: This is an opportunity to be a key contributor to the success of Company sponsored clinical studies. The successful candidate will be an agile thinking and collaborative individual with both a strong track record of hands-on clinical data management experience and leadership capabilities. The successful candidate will have the following mix of personal and professional characteristics:
- BS in a clinical or scientific discipline with 10+ years direct clinical data management experience in a pharmaceutical, academic, or CRO environment.
- Demonstrated ability to problem solve by producing fit-for-purpose data integration solutions and data collection techniques (e.g., queries, edit checks, specifications, etc.) with strong analytical skills to ensure the generation of high-quality, reliable, and statistically sound data that supports clinical/medical decisions.
- Extensive knowledge of EDC tools/platforms (e.g., Medidata, Oracle, Veeva, etc.) coupled with a strong understanding of datasets/programming tools (e.g., ADaM, SDTM, SAS, etc.).
- Broad experience across multiple phases of clinical development and experience in working with different treatment modalities including small molecules, biologics and vaccines is desirable.
- Solid understanding of database and dictionary structures (e.g., MedDRA, WHODrug).
- Excellent organizational, project management, and communication skills required for extensive interactions with CROs and external study partners.
- Comfortable working across several disease areas and modalities. Must be open to change and the unknown with a creative and resourceful nature; a self-starter, proactive and results-oriented with high performance standards.
- Outstanding communication skills, ability to work well with a wide range of internal and external stakeholders to build strong partnerships and alliances inside and outside the organization.
- Demonstrated passion for Company values with a commitment to deliver results against our mission.