Ref #: 27336

Employment type: Permanent - Full-Time

Location: Germany - Home Based

Posted: 03-Mar-2021

Description

For a multinational biopharmaceutical company DOCS is hiring a Biomarker/Biosample Operations Manager (m/f/d). A great opportunity to join one of the leading departments in a leadership position.


Role and Responsibilities:

The Biomarker/Biosample Operations Manager is responsible for providing operational expertise to sites through ownership and management of his assignments.

· Is responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial
· Maintains a patient focus to balance the value of samples versus the complexity of collection, cost to the trial and potential affects upon patient recruitment and burden
· Is responsible for reviewing and providing input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities
· Is responsible for managing the interface between GCO, non-GCO functions and External partners (e.g. CRO, Analytical Labs) to ensure proper planning and cross-functional alignment on deliverables and timelines

What is required :

• Minimum of 3 years operational experience in at least one of the following fields: Clinical trial,
biosample management, PK/ADA, Biomarkers and /or CDx (e.g. Biosample Manager, Clinical
Trial Manager/Associate, Outsourcing Manager, Lab expert or pertinent comparable position).
• Proven training on ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMEA etc.)
• Profound experience in working in a matrix organization and in international teams.
• Project management skills highly desirable, willing to take on and lead special projects, able to
identify risks and problems and to propose appropriate measures when required.
• Excellent IT, presentation, time management and interpersonal skills.
• Experience with Lab Management Systems (e.g. LIMS) is of advantage.
• Excellent written and spoken communication skills.
• Attention to details, analytical thinker & problem solver.
• Able to work autonomously and under time and workload pressure.
• Knowledge in therapeutic areas such as Immunology, Oncology, Immuno-Oncology is an asset.
• Demonstrated experience establishing effective priorities for self, while working with a sense of
urgency, delivering on multiple projects and often dynamic deadlines.
• Experience in developing and implementing agile, creative solutions, helping to solve business
challenges within the line organization, across the company, and in partnership with external
collaborators.
• Highly self-motivated and pro-active, willing to travel (approx. up to 15%)

Why this vacancy is right for you:

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

At DOCS , our people are our greatest asset.

Our primary focus is on the acquisition, management and development of the best candidates in the drug development industry so that they can continue to drive the success of the business and meet the individual needs of our customers.

The DOCS leadership is comprised of key influencers and industry experts, bringing years of experience to the company.

We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a company dedicated to researching, developing, manufacturing and marketing pharmaceuticals that have a direct impact on the health and quality of life of the patients.

Interested?

Please submit your CV to roger.bravomendez@docsglobal.com or call me on
+49 (0) 175 268 7114.

We are looking forward to receiving your application.