Postdoctoral Fellow - Clinical Development Operations (Ridgefield, CT, United States, Connecticut)

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. 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.

Duties & Responsibilities

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

Application Requirements

1. Curriculum vitae

2. Letter of intent  - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth. *Please upload under My Documents, Additional Attachments.

Requirements

Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim OR Ph.D. degree in related discipline

**PharmD candidates preferred.

Highly motivated and shows initiative in contributing to team deliverables

Receptive to receiving and quickly implementing constructive feedback

Ability to work independently within provided guidance from team leads

Adaptable and able to contribute to multiple Therapeutic Areas as needed

Excellent verbal and written communication skills

Proven experience working in a dynamic, high-volume environment handling multiple tasks

Strong computer skills, including Outlook, Word, PowerPoint, and Excel

Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing corporate environment that will allow the incumbent to be productive in rotational experiences

Desired Skills, Experience and Abilities

Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.)

Compensation

Compensation: This position offers a base salary of $80,000.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please  click here.

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