Clinical Program Manager - On Assignment Clinical Research

Location: Tarrytown, NY
Categories: Clinical
Website: www.clinicalsupportorganization.com

Position Description

Summary: The Clinical Program Manager (CPM) oversees and manages all activities related to the conduct of clinical research projects in order to meet deliverables and program objectives. Interacts with various internal and external vendors as well as clinical study sites. Periodically travels to assure compliance with protocol and clinical research project objectives. Clinical research is typically cyclical and some periods during the trial cycle are particularly busy, such as study start-up, enrollment, and database cleaning/lock. These periods may require more time, staffing effort and commitment. This position reports to the Director/Associate Director, Clinical Sciences.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Delivers high quality program deliverables on time and within budget
• Manages, tracks, and troubleshoots a series of related trials within a single program
• Identifies program risks; proactively creates and implements mitigation strategies
• Has operational expertise and communicates effectively operational needs to ensure goals are met
• Keeps apprised of all decisions in order to ensure established goals are attainable prior to the consensus to implement
• Develops work plans, establishes clinical research objectives, assigns tasks and supervises Clinical Trial Managers
• Maintains schedules (timelines) for overseeing assigned clinical research studies and facilitates decision making in order to adhere to timelines
• Provides guidance to Clinical Team by establishing clinical research goals that are aligned with established policies and standards for the department and organization
• Identifies and recommends changes to established practices and policies which affect subordinate resources.
• Directs the activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
•Recommends additional resources based on need to meet goals and milestones
•Clinical site management: answers questions from sites and documents interactions, obtains updates, coordinates supplies, manages drug issues, and collects regulatory documents.
•Data Management: Interacts with Data Management to ensure that data being collected are accurate, data queries are resolved in a timely manner, statistical analysis plan is developed, and data is transferred to client as needed.
•CRO management: Interacts with CRAs and project manager to ensure sites are being monitored appropriately, data is collected in a timely manner, and study is progressing properly.
•Oversees Internal Aspects of Trial: ensures appropriate paperwork to Regulatory Dept., adequate drug supply, and coordination of sample shipments to sample analysis department.
•External Laboratory, Equipment, and Service Vendors: Determines services to be provided and ensures those services are provided according to the study needs and within the budget.
• Interfaces with senior management to report on project and program milestones and to present project needs
•communicate operational aspects of studies in each project
•Assists in preparing scenarios for creative solutions to hurdles
•Is the point person for information on status of different projects in program
•Attends appropriate development meetings
• Provides timely and accurate information to Program Management for program level tracking
• May have full budgetary responsibilities
•Includes review, presentation, approval of initial budget and changes to review bodies as appropriate
•Adherence to budget
•Manages clinical study site payments and other vendor invoices.
• Writes reports: FDA Annual reports, Investigator Brochure and updates, Clinical Study report, Protocols, and Informed Consent forms. These tasks occur and are needed at least once annually.
• May or may not manage lower-level staff (CTMs)

Knowledge, Competencies and Specialized Skills:
• Analytical problem solving experience.
• Working knowledge of clinical research database systems.
• Must be able to develop and present varied and unique ideas.
• Develops and provides challenging yet appropriate assignments and communicates progress toward development goals.
• Strong leadership skills; communicates and demonstrates vision and commitment.
• Effective influence and relationship management skills
• Financial acumen in creating and managing clinical program budget
• Builds successful collaborations with internal and external partners
• Strong communication skills; verbal, written, and presentation
• Broad knowledge and cross-functional understanding of clinical trial methodology
• Knowledge of GCP and ICH
• Directs and coordinates the operation of a program of sufficient size to require the use of subordinate supervisors.

Requirements:
• Bachelor’s degree (B.S.) in the Life Sciences Discipline from a four-year college or university (advanced degree preferred), minimum seven (7) years of clinical research experience in the Pharmaceutical industry, preferably in multiple phases, as well as minimum 2 years management experience.
• Travel may be required approximately 25% of the time; on occasion required to travel frequently by air, rail, and automobile. External work environment may include physician’s offices and hospitals where exposure to pathogens is greater than internal environment.

How to Apply

For immediate and confidential consideration please e-mail a copy of your resume as a word document along with a day time phone number to susan.todd@onassignment.com.

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