Postdoctoral Fellow - Clinical Development Operations

The Clinical Development Operations fellowship is designed to provide the PharmD fellow with an understanding of the history of drug development and how the US Code of Federal Regulations and International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) set the framework under which clinical trials are conducted. To facilitate hands-on training, the fellow will be assigned to work on one or more clinical trials under the supervision of an experienced Clinical Trial Manager (CTM) and/or Clinical Trial Leader (CTL).

The CTM/CTL will be responsible for guiding and mentoring the fellow on the strategic and operational aspects of his/her assigned clinical trials. There may also be an opportunity for the fellow to undertake special projects. Through direct mentoring and rotations, the fellow will gain an understanding of the broad range of career opportunities available to a pharmacist in Clinical Development Operations.

Although the fellow will be based in Study Management & Conduct, he/she will have an opportunity to rotate/shadow through other departments within the broader Medical Department as appropriate. The intention of these rotations is to increase the fellow’s understanding of how the work of specialized functions is critical the overall conduct of clinical trials.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility, and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Clinical Development Operations fellowship is designed to provide the PharmD fellow with an understanding of the history of drug development and how the US Code of Federal Regulations and International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) set the framework under which clinical trials are conducted. To facilitate hands-on training, the fellow will be assigned to work on one or more clinical trials under the supervision of an experienced Clinical Trial Manager (CTM) and/or Clinical Trial Leader (CTL).

The CTM/CTL will be responsible for guiding and mentoring the fellow on the strategic and operational aspects of his/her assigned clinical trials. There may also be an opportunity for the fellow to undertake special projects. Through direct mentoring and rotations, the fellow will gain an understanding of the broad range of career opportunities available to a pharmacist in Clinical Development Operations.

Although the fellow will be based in Study Management & Conduct, he/she will have an opportunity to rotate/shadow through other departments within the broader Medical Department as appropriate. The intention of these rotations is to increase the fellow’s understanding of how the work of specialized functions is critical the overall conduct of clinical trials.

• Select sites for study conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations
• Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals
• All Regulatory Requirements are satisfied prior to trial/site initiation
• Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations
• Set up, manage and review operating unit (OPU) trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes
• Ensure appropriate trial-specific training of OPU internal and external partners in line with Trial Training Plan
• In collaboration with Site Monitoring Lead and Clinical Research Associates (CRAs), ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and BI team to GCP, local regulations, BI Standard Operating Procedures (SOPs) (for BI staff and issue), and adherence to trial protocol, adequate trial supply…