Manager, Clinical Operations

Impax Laboratories, Inc. is a technology based specialty Pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.

Job Summary:  This position will support the Clinical Development Department in coordinating, monitoring and managing clinical studies of IMPAX products in according to Good Clinical Practices (GCP), the Code of Federal Regulations (CFR) and/or International Conference on Harmonization (ICH) guidelines

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Responsibilities:

· Coordinate and contribute to the development of protocols, case report forms (CRFs), informed consent forms, and investigator’s brochures.

· Coordinate and participate in the selection/negotiation and management of activities of CROs, other service providers and investigative sites.  Ensure CROs’ adherence to work scope and budget of all vendors.  Monitor expense reports all service providers.

· Able to plan, execute, and close out a multi-center clinical trial with no or very limited supervision.

· Identify and recruit investigator sites

· Prepare/coordinate investigator meetings, CRA training, including prepare and deliver presentations. Provide clinical expertise to department members and to other cross-functional areas.

· Design and develop study budgets, execution logistics and implementation, timelines, CRFs & completion guideline, drug shipment strategy, enrollment strategy and safety follow up. 

· Coordinate and participate in designing IVRS, study drug labels, lab kits for central lab and other study related tasks.

· Create study-specific source documents, guidelines, and forms to effectively implement protocols.

· When needed, perform or co-conduct pre-study site qualification, initiation, monitoring, and closeout visits. Identify and recommend any needed corrective actions.

· Review/prepare accurate monitoring reports, identify and resolve issues, if needed

· Communicate with external correspondences with minimal or no supervision

· Initiate, monitor and lead direction of clinical trials under limited direction, ensure enrollment, site training needs, and timelines are met.

· Serve as the liaison between all internal and external personnel involved with the study, including contract research organizations, site investigators, study team, and vendors to assist the lead Clinical Research Associate (LCRA) or equivalent, be the primary contact for contract CRA and provide training for junior CRA.

· Attend site/CRO QA audits, as required

· Mentoring and career development activities of direct report(s), if applicable

· Participate in establishing SOPs for clinical operations

· Maintain central study files in a state of audit-readiness

· Other responsibilities related to clinical operations as needed

 

Requirements:

· Nursing degree/Bachelor’s degree in the health or life sciences.  Advanced degree preferred.

· At least 7+ years of industry clinical research experience with related technical experience, including three or more years as a Lead/Senior Clinical Research Associate and CROs management, supervisory experience of direct reports, and execution of multiple trials in parallel.

· Working knowledge of federal regulations, Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines

· Proficient with Microsoft Office word processing, presentation and spreadsheet software

· Ability to communicate and work effectively with a diverse team of professionals

· Flexible and able to thrive in a fast-paced environment

· Travel up to 20% of the time annually