The Clinical 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 Operations. Although the fellow will be based in Study Management & Conduct, he/she will have an opportunity to rotate/shadow through other departments within Clinical Operations 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 a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
Participates in local and global trial teams under the supervision of a Clinical Trial Manager (CTM) /Clinical Trial Leader (CTL)
Trial Preparation, Conduct and Closeout:
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 distribution to sites. Continuous and timely data entry and cleaning, and on time Data Base Lock (DBL).
Trial contact for CRAs, investigators and site staff.
In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the electronic Trial Master File (eTMF) and Clinical Trial Report (CTR) Appendices.
Management and Relationship Responsibilities:
Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level, and supporting CRAs in site contacts.
Collaborates with other BI functions to support Trial Management topics and support integration across Medicine.
Participate in working groups related to Trial Management, represent trial on local and regional level, providing updates on trial within R/OPU.
Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices and regulatory requirements.
Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with BI Values.
Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim.
Strong communication skills in complex cross-functional matrix structures.
Enforce Agility, Accountability and Intrapreneurship (AAI) approach and skills in the trial team and trial management.
Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
Highly developed receptive communication skills, cultural sensitivity
Technical Expertise: Demonstrates knowledge across all aspects of clinical trial operations and execution. Knowledge in a relevant Therapeutic Area is an asset. Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers. Ability to work across several studies and in different Therapeutic Areas. Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements
Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing. Solid communication, project management, networking/stakeholder management and team leadership capability.
Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources.
Ability and willingness to travel domestically and internationally (10-20% of time).
Must be legally authorized to work in the United States without restriction
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Additional Salary Information: The Fellow will receive a competitive stipend and benefits package
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim is focused on science that leads to more health for our patients and their families. The discovery and development of innovative medicines is fundamental to our continued growth and success. Our blueprint for innovation is tailored to accelerate the delivery of breakthrough medicines to the patients we serve by integrating research, pre-clinical and early clinical development, translational medicine, and external partnering functions. This fusion of expertise combined with a dynamic research approach and an increased emphasis on external collaborations means we can effectively incubate the most creative ideas and be among the pioneers in emerging fields of medicine.