Biomarqueur - Clinical Trial Supplies Manager - Sponsor Dedicated

Description

Here at Syneos Health, we are looking for a BIOMARKER OPERATION MANAGER to work sponsor dedicated to a Top Pharma. The job location will be Office Based or Fully Home Based.
The biomarker operation manager will be responsible for overseeing the management of clinical biomarker samples and data collected during several ongoing clinical trials.

He/She will contribute to clinical documentation regarding biomarker sample requirements and monitor operational activities to ensure that the biomarker samples/data are appropriately collected, processed, stored and shipped with the highest degree of quality.
Main responsibilities / job expectations :

- Implement clinical biomarker plans (established by the biomarker lead) into clinical study documentation (e.G. clinical protocols, laboratory manual, ICF) in collaboration with clinical operation teams.

- Provide input to the study feasibility requirements (related to biomarker sample collection, management and logistics), to the service provider regarding biomarker sample and data requirements

- Write and implement Biomarker/Biobanking Management Plans

- Work closely with clinical operation and data management teams and CROs, to monitor ongoing biomarker activities:


- Monitor appropriate collection, processing, tracking, logistics as defined in laboratory manuals, sample flows and sample management plans

- Perform reconciliation of biomarker samples to ensure that samples were collected according to protocol, ICF and laboratory manual (e.G. monitor that ICF was signed for collected biomarker/biobanking samples, that the correct samples were collected at visits foreseen in the protocol)

- Follow up with Central Laboratories on issues/deviations regarding biomarker samples and data. Ensure that adequate actions are implemented for samples/data collected in deviation.

- Review biomarker data (review of the data tables and listings as defined in the Statistical Analytical Plan)

- Drive compliant management of biobanking samples in long term storage CRO

- Perform final biobanking sample reconciliation before database lock

- Contracting service provider for the long term storage

- Collaborate with central laboratories and data management to generate SDTM sample listing

- Upload sample trackers in appropriate tools (LIMS).

- Coordinate biomarker sample destruction at the end of the trial or at the end of the storage period
Qualifications

Key required competencies :


- 3+ years' experience in pharmaceutical industry or in biotech, including 1+ years' experience in clinical sample operations

- Good working knowledge of clinical development, clinical operations, clinical sample management, quality assurance

- Comfortable working in a fast-paced environment

- Comfortable working in a matrix team

- Good problem-solving skills

- Good scientific written, interpersonal communication

- Strong familiarity with good clinical/laboratory practices

- Experience working with CROs

- Experience in biomarker research will be a plus
Benefits

- Competitive remuneration package with excellent benefits

- Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization

- Opportunity to work within a successful and rewarding environment
Are you interested?
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.
To find out more about our company and search and apply for other open jobs please visit our website
About us:

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
Disclaimer:


Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.