Website Lenox Executive Search
12++ month Contract role with strong potential to extend and/or convert to permanent for the right candidate. Pay is flexible and commensuate with experience.
- Clinical trial experience
- Data management experience
- SAS platform (not programming) in pharma desired
- Biobanking experience
Lenox Executive Search is seeking an experienced Sample & Data Management Specialist to fill a Temp-to-Perm contractual role with a global pharmaceutical company in Cambridge, MA. This role will require partial onsite (2-3 days per week) work.
REQUIRED EDUCATION/SKILLS for the Sample & Data Management Specialist:
- MS with 3+ years’ experience, or BS with 5+ years’ experience. Pharmaceutical / Biotech industry experience required.
- Strong working knowledge of clinical operations and how data flow occurs as part of an industry-sponsored clinical trial.
- Expert communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority.
- Broad and strong network in the industry, biotech, CRO communities, and health authorities.
- Have a strong understanding of the clinical trial sample and data lifecycle.
ACCOUNTABILITES of the Sample & Data Management Specialist:
- Candidate should have prior experience with either clinical sample tracking or biobanking LIMS systems and have a solid technical understanding of integration features particularly around data flow.
- Technical knowledge to maintain and transfer electronic files through sFTP, APIs etc.
- Provides guidance and oversees data flow from internal and external data platforms.
- Experience in regulatory and quality standards around data requirements.
- An understanding of biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.), and the types of data generated from such platforms, is highly desirable.
- Familiarity and experience with handling clinical data sets, clinical data standards (e.g. CDISC, SDTM) and related industry standards.
- Highly organized, highly detail-oriented, able to excel in a matrix team environment, with superior written and verbal communication skills.
OBJECTIVES for the Sample & Data Management Specialist:
- The successful candidate will be responsible for working closely with LIMS vendors, and internal informatics specialists, in the installation, validation and implementation of biobanking and sample tracking LIMS systems.
- Responsible for initial and ongoing QA of all LIMS data imports, ICF attributes, child specimens and derivatives, as well as clinical data.
- Work with internal and external partners to develop processes and workflows for data flows, data mapping, data security and data QC.
- Work with data standards, data management, biostatistics and other key stakeholders to maintain and update existing biomarker data standards for clinical trial studies.
- Work with clinical teams to provide controlled terminology and mapping instructions for clinical biomarker data.
- Work with Translational Lead Scientists and Bioassay Scientists to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
- Interface with clinical project teams to mitigate issues with clinical biomarker data standards.
- Interface with vendors to mitigate issues with clinical biomarker data transfers, security and reporting.
- Work with internal and external stakeholders in refining clinical and biobanking ontologies to be used within LIMS systems.