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Senior Clinical Project Manager

Company: Integrated Resources
Location: Somerville
Posted on: June 22, 2022

Job Description:

Job DescriptionPositionJob Title: Senior Clinical Project ManagerDivision / Function: Medical & Regulatory AffairsManager (Name, Job Title): Director, Medical Affairs OperationsLocation: Cambridge, One Main Street

Summary / purpose of the position

The Senior Clinical Project Manager (Senior CPM) is responsible for studies (Phase IV and Patient Registry) conducted for **-US Medical & Regulatory Affairs with respect to: planning, implementation, coordination, reporting, and overall resource definition.
The Senior CPM ensures that clinical studies are completed according to the Protocol, Good Clinical Practice (GCP) guidelines and **s or the Contract Research Organizations (CRO) SOPs. The Senior CPM ensures timely delivery and budget adherence in order to assist in the delivery of US Medical & Regulatory Affairs objectives

Main responsibilities / job expectations Has overall responsibility for assigned Clinical Studies from an Operations perspectiveResponsible for the direct oversight of all outsourced providers, i.e. CROs, CRAs, central laboratories, Electronic Data Capture (EDC), etc.Responsible for organizing and delivering relevant Clinical Study training to other Clinical Operations / CRO staffFoster and develop a team approach to all activities associated with the implementation of clinical studies; the team includes CROs Monitors/Clinical Research Associates (CRAsEstablish and maintain excellent professional relationships between the company and external experts in conjunction with Project PhysiciansLead the feasibility and site selection processes for the Medical Affairs Studies with the support of the ** Medical Science Liaisons (MSL) and CROsResponsible for preparing detailed timelines and establishing clinical study milestones for assigned projects, ensuring they are performed according to the Protocol, Good Clinical Practice guidelines, and SOPs and further ensuring timely delivery and budget adherenceIdentify, in conjunction with the medical Therapy area, high quality investigators and study sites for the conduct of clinical registration studiesReview and recommend amendments to the study protocols to ensure the study feasibility and to subsequently plan and organize work schedulesEnsure, in conjunction with the Regulatory, Pharmacovigilance and Data Management Departments, that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activitiesParticipate in the selection of CROs and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set; manage CRO/CRA relationship as requiredPrepare and/or manage the production of all documents necessary to implement and monitor the study in a professional, high quality and timely mannerAs applicable, manage and train CRAs, co-monitor study, review and approve site visit reports, ensuring timely and appropriate follow up of issues raised by monitors; conduct site visits as requiredEnsure regular and timely liaison with appropriate Medical & Regulatory entities and provide regular and timely reports on all site performance changes including Product, schedules and resources; provide guidance and support to other clinical operations support staff so that the administration activity/CRA activities are carried out efficientlyEnsure preparation of confidentiality agreements and site investigational contracts according to internal ** guidelines and liaise with legal as appropriateContribute proactively to the efficient operation of the Medical Affairs Group and to systems (eDC, CTMS) and processes being planned and implemented; participate in the training on and preparation, review, updating of SOPParticipate in the preparation and review of clinical study reports as assignedParticipate in the preparation and review of regulatory submission documents as needed, including IND/NDA submissions, and IND/NDA update and supplementsEnsure the completeness of the Clinical Trial Management SystemsEnsure all the tasks related to the ** Electronic Data Capture (EDC) systems are completed including the training and regular support of all users including external Monitors and Site personnelSupervises and/or Performs User Acceptance Testing of the eCRFPrioritize and schedule all matters related to the clinical studiesChair internal and external meetings (i.e. CRA/investigator meetings) related to the clinical study as designatedSupervise the schedule of work for Medical Affairs personnel and CROs within the companyKnowledge, abilities & experienceEducation / Certifications: Bachelors degree required, advanced degree preferredExperience:Substantial relevant experience of pharmaceutical drug development including project management of domestic and international clinical studies for at least 5 years (Pharma or CROs)Two or more years of experience managing Phase IV and / or Registry trials is preferredExperience with expanded access programs is a plus Excellent knowledge of Good Clinical Practice (GCP)/ICH regulations.Experience preparing clinical study documentation.Experience managing and developing relationships with Contract Research Organizations (CROs).Experience compiling and managing clinical study budgetsKey Technical Competencies RequiredAn understanding of the drug development process and a good knowledge of the pharmaceutical industryExcellent knowledge of regulatory requirements (ICH, GCP, Legal constraints)Excellent Leadership skills and capability to work within a team as leader and team playerExperience working with multidisciplinary groups (internal & external) and ability to work within a matrix environmentManage multiple Clinical and Medical ProgramsExcellent organizational and management skillsExcellent verbal and written communication skillsStrong proficiency with Microsoft software (Word, Excel, PowerPoint and Outlook)Excellent attention to detail, organizational and time management skills to prioritize and coordinate workload with minimal supervisionStrong communication skills, verbal as well as written Job SnapshotEmployee Type:Full-TimeLocation:Cambridge, MAJob Type:ManagementExperience:Not SpecifiedDate Posted:6/11/2022

Keywords: Integrated Resources, Somerville , Senior Clinical Project Manager, Executive , Somerville, Massachusetts

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