FierceBiotech and FiercePharma Jobs
Clinical Program Manager - SRG Woolf Group
Aug 18
Location: Wakefield, MACategories: Clinical
Website: http://www.srgwoolf.com
Position Description
Our client, a biopharmaceutical company near White Plains, NY is seeking an experienced Clinical Program Manager to join their team. Relocation will be offered to highly qualified candidates!
PURPOSE OF POSITION: The Clinical Program Manager 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. Essential Duties and Responsibilities include, but are not limited to, the following: Delivers high quality program deliverables on time and within budget. Performs job duties with minimal guidance. 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 effectively communicates 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. 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, Data Management, and CRO management experience essential. Interacts with CRAs and project manager to ensure sites are being monitored appropriately, that data is collected in a timely manner, and study is progressing properly. Oversees internal aspects of trial as well as 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. Attends appropriate development meetings. Provides timely and accurate information to Program Management for program level tracking. May have full budgetary responsibilities. 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. Directs and coordinates the operation of a program of sufficient size to require the use of subordinate supervisors.
EDUCATION AND SKILLS: 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. Must have analytical problem solving experience and working knowledge of clinical research database systems. Must be able to develop and present varied and unique ideas. 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.
