Boehringer Ingelheim
Post-Doctoral Fellow - Clinical Development Operations
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Post-Doctoral Fellow - Clinical Development Operations
Description
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. 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 mentor the fellow on the strategic and operational aspects of the assigned clinical trials. There may also be opportunities to undertake special projects. Through direct mentoring and rotations, the fellow will gain an understanding of career opportunities available to a pharmacist in Clinical Development Operations. The fellow will be based in Study Management & Conduct with opportunities to rotate/shadow through other departments within the Medical Department as appropriate to increase understanding of how specialized functions contribute to 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 patients and customers. The company emphasizes collaboration, mobility, and work-life balance, with competitive compensation and benefits. Duties & Responsibilities
Trial Preparation, Conduct, and Closeout: Select sites, deliver the trial according to the protocol within timelines, and in compliance with ICH-GCP and other regulations. Lead and support local trial teams and investigative sites in timely preparation of trial documents, contracts, and approvals. Ensure regulatory requirements are satisfied prior to trial/site initiation. Set up and manage external suppliers when needed for trial operations. Set up, manage and review operating unit trial budgets with timely updates as trial changes occur. Ensure appropriate trial-specific training of internal and external partners in line with the Trial Training Plan. Collaborate with Site Monitoring Lead and CRAs to monitor site and BI team adherence to GCP, regulations, SOPs, and the trial protocol; ensure adequate trial supply distribution. Data entry and cleaning with timely DBL; serve as trial contact for CRAs, investigators and site staff. Assist with collection and archiving of required documents for the eTMF and CTR Appendices. Management and Relationship Responsibilities: Develop and maintain relationships with external experts and investigational sites; coordinate cross-functional collaboration among Clinical Operations and Medical Affairs; support CRAs in site contacts. Collaborate with other BI functions to support Trial Management topics and cross-functional integration. Participate in working groups related to Trial Management and represent the trial at local/regional levels. Application Requirements
Curriculum vitae Letter of intent describing how a fellowship at Boehringer Ingelheim can advance your career; upload under My Documents, Additional Attachments. Requirements
Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned before the start date OR Ph.D. in a related discipline PharmD candidates preferred Highly motivated with initiative; able to work independently with guidance Receptive to feedback and able to adapt quickly Ability to contribute to multiple Therapeutic Areas; strong verbal and written communication Experience in a dynamic, high-volume environment with multiple tasks; strong computer skills (Outlook, Word, PowerPoint, Excel) Foundational understanding of drug development processes and regulatory considerations Desired Skills, Experience and Abilities
Prior pharmaceutical industry experience (e.g., internship or APPE rotation) is preferred but not required. Compensation
Compensation: This position offers a base salary of $80,000. The role may be eligible for a variable or performance-based bonus and other compensation elements. Benefits information is available upon request. About Boehringer Ingelheim
We value diversity and collaboration and are committed to developing our employees. We support health, mobility, networking, and work-life balance, and invest in programs to improve global healthcare access. For more information, visit https://www.boehringer-ingelheim.com
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Description
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. 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 mentor the fellow on the strategic and operational aspects of the assigned clinical trials. There may also be opportunities to undertake special projects. Through direct mentoring and rotations, the fellow will gain an understanding of career opportunities available to a pharmacist in Clinical Development Operations. The fellow will be based in Study Management & Conduct with opportunities to rotate/shadow through other departments within the Medical Department as appropriate to increase understanding of how specialized functions contribute to 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 patients and customers. The company emphasizes collaboration, mobility, and work-life balance, with competitive compensation and benefits. Duties & Responsibilities
Trial Preparation, Conduct, and Closeout: Select sites, deliver the trial according to the protocol within timelines, and in compliance with ICH-GCP and other regulations. Lead and support local trial teams and investigative sites in timely preparation of trial documents, contracts, and approvals. Ensure regulatory requirements are satisfied prior to trial/site initiation. Set up and manage external suppliers when needed for trial operations. Set up, manage and review operating unit trial budgets with timely updates as trial changes occur. Ensure appropriate trial-specific training of internal and external partners in line with the Trial Training Plan. Collaborate with Site Monitoring Lead and CRAs to monitor site and BI team adherence to GCP, regulations, SOPs, and the trial protocol; ensure adequate trial supply distribution. Data entry and cleaning with timely DBL; serve as trial contact for CRAs, investigators and site staff. Assist with collection and archiving of required documents for the eTMF and CTR Appendices. Management and Relationship Responsibilities: Develop and maintain relationships with external experts and investigational sites; coordinate cross-functional collaboration among Clinical Operations and Medical Affairs; support CRAs in site contacts. Collaborate with other BI functions to support Trial Management topics and cross-functional integration. Participate in working groups related to Trial Management and represent the trial at local/regional levels. Application Requirements
Curriculum vitae Letter of intent describing how a fellowship at Boehringer Ingelheim can advance your career; upload under My Documents, Additional Attachments. Requirements
Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned before the start date OR Ph.D. in a related discipline PharmD candidates preferred Highly motivated with initiative; able to work independently with guidance Receptive to feedback and able to adapt quickly Ability to contribute to multiple Therapeutic Areas; strong verbal and written communication Experience in a dynamic, high-volume environment with multiple tasks; strong computer skills (Outlook, Word, PowerPoint, Excel) Foundational understanding of drug development processes and regulatory considerations Desired Skills, Experience and Abilities
Prior pharmaceutical industry experience (e.g., internship or APPE rotation) is preferred but not required. Compensation
Compensation: This position offers a base salary of $80,000. The role may be eligible for a variable or performance-based bonus and other compensation elements. Benefits information is available upon request. About Boehringer Ingelheim
We value diversity and collaboration and are committed to developing our employees. We support health, mobility, networking, and work-life balance, and invest in programs to improve global healthcare access. For more information, visit https://www.boehringer-ingelheim.com
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