Apple & Associates, Inc.
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Global Pharmaceutical company which focuses in Rare Disease, Oncology and Infectious Disease is hiring a
Biosmaple Operations Manager
Must have GCP experience and Sponsor experience (Biotech or Pharmaceutical)
One year w-2 contract with full benefits offered
Or can go permanent Full time
Send resume if interested and qualified:Company is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay laboratories and CROs. This position may report directly to the Company’s Head of Therapeutic Operations or to a Clinical Biomarker Director. This position will work collaboratively across all therapeutic area teams for to ensure implementation, compliance and support of biosample management for clinical trials conducted by Company.
Responsibilities In collaboration with individuals from Clinical Biomarker Director and Research groups to support the evaluation of technologies to identify, define and implement the biomarker strategy to support the clinical development of Company’s compounds
Provide support to the clinical teams driving agreed upon biomarker sample management for the clinical projects.
Support the review of the biomarker sections of the clinical protocol, study/lab manuals and consent forms
Build cross functional process for sample flow, biorepository usage
Develop and provide ongoing sample training to team members
May participate in committees and work streams that support process and procedure for standardized language, biomarker usage, and data reporting
Work with clinical sites, as needed, to ensure accurate and appropriate sample collection to support the biomarker strategy
Serve as a point of contact for the biomarker sample repository
Support the Clinical Biomarker Directors in the analyses of biomarker data, collaborating with biostatisticians, bioinformatics, clinical and research team members
Support teams to ensure biosamples are compliant with informed consent and GCP/ICH
Qualifications Bachelor’s degree in a science-based subject; Advanced degree preferred
Minimum of 5 years of clinical research experience which must include sponsor experience
Direct experience with clinical sample management
Prior process development experience needed
Familiarity with databases is essential
Solid understanding of good Clinical GCP/ICH is required.
Strong communication skills and attention to detail
At Apple & Associates, we understand that relationships are what make us stand apart. Whether you are a client or a candidate, you are an extension of the Apple & Associates’ family. Many of our recruiters have been with the company since its earliest days. They take great pride in the relationships they build; always emphasizing high standards, ethics and quality service. Our President, Debi Apple started her recruiting career in Aiken, South Carolina. She quickly became a top producer and leading authority in recruiting for the medical device, pharmaceutical and consumer product industries. Her passion and drive led her to open Apple & Associates in 1993. Under her leadership, Apple & Associates has grown to be one of the leading recruiting firms in these industries. Our company is proud to represent two of the largest medical device and pharmaceutical companies in the U.S., Covidien (formerly known as Tyco Healthcare) and our first and longtime client, Becton Dickinson. Now headquartered in Chapin, South Carolina, Apple & Associates has offices from coast to coast, offering regional recruiting expertise throughout the U.S. and Latin America. Our searches and permanent placements represent all levels, from CEO to staff level positions.