Sr. Biomarker Scientist
Proclinical is currently recruiting for a Sr. Biomarker Scientist with a globally leading pharmaceutical company located in Redwood City, CA. Successful candidate will have experience working with clinical trials, clinical biomarker operations, and have a strong knowledge of FDA and/orEMA Regulations, ICH guidelines, and GCP's.
- Provide hands-on support to enable biomarker assay implementation in clinical trials, including sample and data management, and CRO management.
- Review Clinical Biomarker sections in key clinical documents including Protocols, Informed Consent Forms, Contracts, and Clinical Study Reports. Provide input into trial-specific agreements and statements of work with vendors.
- Provide operation support to Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines
- Maintain open and frequent communication with various departments functions such as Clinical Operations. Maintain a positive working relationship with internal/external customers. May assist CRA in training sites on sample collection/handling.
- Adhere to applicable country regulations, legal requirements, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs).
Skills and Requirements:
- Proficient in the conduct of clinical trials and associated activities and responsibilities, as well as experience interacting with clinical trial teams; strong background in oncology a plus.
- Previous experience with Clinical Biomarker Operations.
- Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines.
- Excellent communication and interpersonal skills, including problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player.
- Able to work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites.
- Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy.
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies.
- Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus.
- Understanding of Translational Sciences and Companion Diagnostic development is a plus.
- Project Management experience a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Catherine Nguyen at (+1) 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.