sr specialist biomarker operations, clinical.

　　cambridge , massachusetts

　　posted january 18, 2024

　　job details

　　summary

　　$55 - $62.50 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47254

　　job details

　　job summary:

　　As the largest staffing and recruitment agency in the world, we can commit to finding 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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

　　location: Cambridge, Massachusetts

　　job type: Contract

　　salary: $55.00 - 62.50 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　responsibilities:

　　The company is seeking a Biomarker Operations Sr. Specialist to support the clinical teams and to work across its clinical trials as well as with external biorepositories, assay laboratories and CROs. This position will work collaboratively across all therapeutic area teams to ensure implementation, compliance and support of biosample plans and management for clinical trials conducted by the company.

　　Provide logistical support for implementation of clinical biomarker sample management plans in company clinical trials

　　Review of biomarker sections of clinical protocols, lab manuals and consent forms, and lead clinical sample kit development.

　　Track and manage processes throughout clinical sample lifecycle and biorepository usage

　　Ensure standardized language for sample information and standardized processes sample reconciliation

　　Support clinical teams to ensure biosamples are compliant with informed consent and GCP/ICH

　　Oversee clinical assay vendors (routine sample analysis meetings, address sample issues, sample shipments)

　　Track ongoing biospecimen quality issues at global central labs and 3 rd -party vendors

　　qualifications:

　　Bachelor's degree in a life science-based subject; advanced degree preferred

　　Minimum of 3 years of clinical research experience which must include sponsor experience

　　Direct experience with clinical sample management

　　Prior process development experience is very helpful

　　Familiarity with databases is helpful

　　Solid understanding of GCP/ICH is required

　　Strong communication skills and attention to detail

　　Demonstrated ability to multitask

　　skills: GCP (Good Clinical Practice), ICH Regulations

　　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.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.