Senior Clinical Program Manager

Position Summary: The Sr. Clinical Program Manager (CPM) leads the clinical development team in executing the clinical plan by providing project management, process and therapeutic area expertise. The CPM achieves this while ensuring on-time and on-budget fulfillment of deliverables. The CPM supports non-trial, trial and project level assignments within the team. The CPM will serve as the single point of contact for Contract Research Organizations (CRO) to ensure good communication and on time delivery of project milestones. Key Responsibilities: Clinical Trial Process, Project Management, Regulatory Activities sand Execution * Manages the overall trial timeline, development, and implementation throughout the clinical trial * Networks the timeline and work plan with the clinical development team and vendor(s) to ensure alignment * Will communicate with CROs, investigative sites, advisors, and consultants to discuss clinical trial feasibility and implementation issues, as needed * Ensures Project plan is accurate and tacks project milestone dates * Is the single point of contact for the CRO PM to ensure proactive communication * Management oversight of CRO performance throughout study implementation * Coordinates study update meetings and facilitates cross functional communication * Coordinate the development of the risk management plan at the trial level and communicate to upper management. * Proactively ensures trial documentation is complete (i.e. protocol violations, investigator/ERB information, and other elements that are required for the clinical study report or submission) * Works jointly with Procurement to review sourcing alternatives, providing needed study specifications in order to obtain reliable study cost, human resource, and timeline estimates * Coordinates contract reviews with third party vendors, and provides input to Procurement regarding lack of clarity or needed changes in contract conditions * Generates clinical study specifications for third party bidding with Procurement * Proactively ensures that all needed regulatory documentation is completed and submitted by the Contract Research Organization (CRO) prior to study initiation * Ensures that all study project files are maintained according to policies and procedures * Ensures appropriate sign-offs and submissions of clinical trial and regulatory documents * Utilizes appropriate tracking and forecasting tools (e.g. budget, timeline projections, enrollment) throughout the trial * Anticipates, understands and addresses compliance or quality issues that may be identified during the course of the trial * Generates clinical trial cost forecasts. Establishes and monitors the trial budget (grand and non-grant), and tracks invoices Therapeutic Area Expertise * Contribute on protocol and CRF development and final report completion * Answers trial protocol/technical questions from customers and business partners * Assists in the preparation of clinical development and/or scientific materials for various meetings. May be requested to present on scientific or process-related issues * Partners with the Medical Director and/or presents study information at various clinical meetings and therapeutic congresses as needed * Assists in the preparation of the publication strategy for assigned indication, as well as the creation of abstracts, posters, and manuscripts for completed studies Submission/Commercialization Support * Provides scientific consultation for clinical and regulatory documents such as Clinical Investigation Brochures (CIBs), New Drug Applications (NDAs), safety updates, interim study reports, final study reports, abstracts, publications and manuscripts * Coordinates the clinical content/documents contributing towards NDAs, sNDAs, briefing documents, regulatory responses, etc. * May contribute in clinical submission document content authoring, editing, publishing * Responsible for managing/participating in QC/Validation process for clinical submission documents Qualifications required: * Four-year degree, preferably in a scientific or health-related field. Minimum of three years clinical trial experience preferred * Strong leadership skills, with previous experience leading cross-functional teams or projects preferred * Strong communication skills (verbal and written) are required * Excellent problem-solving abilities * Strong self-management and organizational skills with the ability to multitask * Strong Project Management skills * Entrepreneurial spirit Previous Applicants: Email: Password: If you do not remember your password click here.

Please refer to job code 645 when responding to this ad.

Category:	Healthcare/Social Services
	> Other Healthcare
Location:	Parsippany, NJ
County:	Morris County
ZIP Code:	07054
Pay Rate:	Open
Job Terms:	full time
Company:	The Medicines Company
Phone:	email only please
Fax:	email only please