Ref #: 24725

Employment type: Permanent - Full-Time

Location: United States-Remote

Posted: 19-Oct-2020

Description

The Bioanalytics Operations Manager is an operational role within the BioSample Operations group in Global Clinical Operations to enable operational processes and the delivery of clinical bioanalytical data from Contract Research Organization (CRO) to support clinical development programs. As an integral member of a team, the Bioanalytics Operations Manager will be working closely with other clinical study team members to perform a diverse range of operational activities, which directly impacts the success of the clinical programs he/she supports.

Responsibilities:
• 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.

Qualifications:
• Experience in NBE and/or NCE bioanalysis and bioanalytical assay development are highly desirable.
• Technical experience with Ligand Binding Assay, Cell-Based Assay, and LC-MS is desirable.
• Experience related to clinical study management is a plus.
• Experience working with a CRO or external partner is desired.
• Working experience in GLP or GCP regulated environment is an advantage.
• Good understanding of drug development and discovery processes is desirable.
• Prior project coordination and/or project management experience is desired.
• Excellent self-organizational and time management skills are required. Attention to detail is essential.
• Strong computer skills with Microsoft Excel, Powerpoint, and Word are required.
• Proficient in communication with impact.
• Fluent spoken and written English.
• Good intercultural understanding.
• 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.

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.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.