job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $34.36 - 40.43 per hour
work hours: 9 to 5
- The Clinical Biomarker Innovation and Development group at Takeda is seeking an outstanding candidate who will effectively execute the clinical study start up process across all Takeda therapeutic areas.
- The incumbent will work in close partnership with the clinical biomarker, diagnostics and bioanalytical sciences groups within CBID, clinical science & operations, drug discovery & data standards within Takeda, as well as external partners.
- As a Clinical Biomarker Sample Manager, the candidate will be responsible for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples.
- Coordinate and drive completion of sample management plans for all clinical trials supported by CBID.
- Review key study start up documents such as clinical study protocols, requests for proposals for central laboratory services, budgets, contracts and laboratory manuals to verify that biomarker samples are collected as specified in the sample management plan.
- The candidate will be responsible for developing and executing the bioanalytical and biomarker operations and companion diagnostics plan for programs, including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of budget and resources (in collaboration with the CBID scientists and other key internal partners) and development of high level operational strategies.
- Coordinate assigned clinical studies and programs by planning for and managing timelines for various deliverables and facilitate communication between CBID scientists and CRO labs as well as negotiate and ensure all high priority timelines for data delivery and reports are met.
- Work closely with Translational Lead Scientists and Bioassay Scientists to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
- Interfaces with clinical project teams to mitigate issues with clinical biomarker data standards.
- Interfaces with vendors to mitigate issues with clinical biomarker data transfers and reporting.
- Oversee finalization of data transfer agreements (DTA) and ensures that data is transferred between bioassay vendors and CRO to meet clinical trial and translational timelines.
- Responsible for creating effective biomarker sample collection language in model patient informed consent forms and for review of changes made during the IRB/EC approval process
- Work closely with key line functions such as Legal, Clinical Operations, Clinical Outsourcing and outside vendors to identify and provide solutions to issues regarding biomarker sample collection in clinical trials
- Responsible for documentation, SOPs and protocols related to biomarker samples.
- Utilize vendor tracking systems in order to report progress, address issues and resolutions.
- Address questions and requests from CRO or clinical team on sample collections, shipment to vendor for testing, analysis and final disposition.
- BS or MS in life scientific discipline with 2-8 years of biotechnology or pharmaceutical industry experience in drug development and clinical trial project management.
- Excellent knowledge of clinical trials and understanding of the role of biomarkers in clinical studies
- Familiarity and experience with CDISC/SDTM and related industry standards
- An understanding of various biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.) is highly desirable
- Works successfully under pressure and with tight timelines.
- Self-motivated, highly independent, organized & detail-oriented
- Excellent written, organizational and interpersonal communication skills necessary to interface with outside vendors and internal team members across function areas.
- Technical knowledge to maintain electronic files and experience with LIMS database systems.
- Microsoft Office proficiency
- Some domestic and international travel to company sites, biomarker vendors, and regulatory agencies may be required.
skills: Assay Development, CDISC, Laboratory Information Management Systems (LIMS), Flow Cytometry
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.