Senior Clinical Project Manager
Company: Integrated Resources
Location: Somerville
Posted on: June 22, 2022
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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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