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Clinical Project Lead Jobs

New Haven, Connecticut
<p> Clinical Project Lead AP7308339</p><p> New Haven, CT 06510</p><p> 6 Month Contract</p><p> Job Summary</p><p> Clinical Project Lead (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors. The CPL will drive continuous improvement of processes and sharing of best practices in clinical research. He/she will also ensure inspection readiness and compliance for the study team, CRO, vendors and investigator sites.</p><p> Responsible for leadership and management of the clinical study team, focusing on proactive management of patient safety and data integrity. Responsibilities include design, execution and reporting of studies; drives the definition of the scope of work, selection, management and oversight of CROs and vendors; approves selection of clinical trial sites. Provides status updates and performance metrics to senior management. Leads the development, review and approval of all study documents.</p><p> Principal Responsibilities</p><p> Direct the creation and execution of clinical trial activities in accordance with client SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection. Lead cross functional clinical study team to achieve study milestones. Interact with internal and external groups to achieve study milestones. Determine study requirements, define specifications, and initiate and lead the selection of third party vendors. Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality Manage clinical study budgets within agreed variance. Communicate clinical studies performance data to other members of the management and scientific team. Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets. Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report. May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates. May participate in and/or lead department initiatives Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.</p><p> Qualifications</p><p> A solid clinical operations professional with at least 5 years experience in clinical research. Must have proven technical leadership skills. Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, and regulatory affairs. Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization. Knowledge of team development principles and successful implementation of the same is desirable. Effective management and oversight of CROs plus a track record of ensuring GCP compliance and risk management of clinical studies is expected.</p><p> Education</p><p> Minimum requirement: Bachelors degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. Advanced degree is desirable. PMP certification desirable. Major Skills (Technical & soft skills)</p><p> Excellent interpersonal and influencing skills. Ability to effectively lead a cross-functional team in a matrix environment. Proven problem solving and timely decision making skills. Excellent leadership, risk management, planning and project management skills. Strong verbal and written communication and presentation skills. Ability to effectively interact with all levels of professionals and support staff. Management and oversight of CROs. Participate in continuous improvement initiatives in the department. Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential.</p>
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