Ref #: 27673

Employment type: Permanent - Full-Time

Location: Germany - Home Based

Posted: 16-Mar-2021

Description

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


Role and Responsibilities:

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

• Represents BioSample Operations group on multiple clinical study teams. Responsible for addressing clinical study teams’ requests related to Pharmcokinetic (PK) and immunogenicity data either directly or via coordination with other clinical study team members, particularly the project representative and clinical pharmacologist.

• Oversees clinical PK and immunogenicity sample flow and data transfer process.

• Support contracting activities with bioanalytical CROs including execution of contracts and change orders, organizing and filing all contract documents.

• Support budget planning for outsourced studies.

• Support publication of bioanalytical study reports in the regulated database.

• Facilitate document filing related to inspection readiness.

• Accountable for ensuring CRO oversight activities related to outsourced bioanalytical studies are performed according to the agreed timelines and quality and in compliance with current guidelines and internal standards.

• Organize meetings and write meeting minutes.


What is required :

•PhD, Master’s, or bachelor’s degree in biomedical sciences or related fields with 0-3 years (for PhD candidates) and 3-5 years (for candidates with Master’s degree), and 6+ years (for candidates with bachelor’s degree) of post-graduate experience in the life sciences industry.

• 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.
• 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.

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.