Associate Scientist III/Bioanalytical Study Manager
- Cambridge, MA
- Region: US
Support study management and operational aspects of bioanalytical and biomarker outsourcing by coordinating Biomarkers and DMPK clinical study activities and effectively meeting study and program specific timelines and milestones. Assume primary responsibility for interfacing between the Biomarker and Bioanalytical scientists, Global Clinical Operations and various contract sites as needed and appropriate.
II. PRINCIPAL DUTIES & RESPONSIBILITIES:
A. Essential Functions:
- Facilitate establishment of contracts detailing specific assay, report and timeline requirements with CROs selected to perform bioanalytical sample testing
- Serve as Biomarkers clinical study team representative
- Oversee operational aspects of bioanalytical and biomarker assay outsourcing required for clinical studies with no direct supervision
- Oversee testing of clinical samples in specialized bioanalytical and biomarker clinical assays with no direct supervision
- Coordinate input into clinical study documents such as the protocol, scope of work, CRFs and data and report delivery timelines
- Coordinate the timing of sample testing as well as monitoring study activities at contract sites
- Manage multiple studies across several programs and therapeutic areas
- Manage outsourcing budgets, agreements and timelines as needed
- Initiate bioanalytical and biomarker development, transfer, validation and testing work contracts
- Interact with clinical data management group on bioanalytical and biomarker data deliverables
- Oversee generation and completion of assay performance reports
- Review assay performance reports and make recommendations for changes
- Conduct technical audits of vendors as needed
- Follow procedures according to established SOPs and other department guidelines
B. Additional Functions:
- Will need to have understanding of large and/or large molecule technologies
- May write Standard Operating Procedures
- May act as a technical subject matter expect at compliance and regulatory audits
- Other duties as assigned by supervisor
- III. JOB DEMANDS:
- Good understanding of clinical study operations
- Ability to travel to CRO sites within and outside the USA when needed (very limited travel)
- Good problem-solving skills
- Excellent planning, organizational and communication skills
- Attention to detail.
- Excellent interpersonal skills
- Work independently and as part of a team
- Ability to maintain a healthy work/life balance. The role may necessitate working evening and/or weekend hours as necessary to meet project demands.
IV. JOB IMPACT:
- Erroneous decisions in performing responsibilities can negatively impact drug development timelines.
- Bachelor’s degree in a biological science
- 2-4 years industry experience.
- Experience working with contract research organizations
- Experience with project management and timeline management
- Previous laboratory experience performing PK, Immunogenicity, Biomarker, Flow Cytometry, PCR, or LCMS assays or within specialty technology
- Previous experience in drug development and/or clinical trial operational teams
All your information will be kept confidential according to EEO guidelines.