Clinical Trial Manager at Apex Systems, Inc
Posted in Information Technology 17 days ago.
This job brought to you by Professional Diversity Network, Inc
Type: Full Time
Location: Summit, New Jersey
Operational direction of one or more cross-functional study team(s) and/or oversight of one or more Contract Research Organization (CRO) teams
Provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations,and applicable SOPs
Oversight of study execution utilizing available performance metrics and quality indicators
Oversight of clinical monitoring quality and adherence to established processes and plans
Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
Maintenance/updating of data as appropriate in project management tools including CTMS
Study Planning and Conduct
Facilitation of country and site feasibility/selection processes
Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
Oversight of clinical supply forecasting/management
Development of the subject recruitment/retention strategy
Participation in clinical service provider (vendor) selection, specification development, and management/oversight
Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
Development/coordination of training for study team, investigational sites, and vendors
Oversight of required country regulatory and country/site IRB/IEC approvals/notifications
Participation in Serious Adverse Event (SAE)reconciliation process
BA / BS or higher degree in relevant discipline
Direct experience managing oncology trials
Minimum 6 years clinical trial management experience at a CRO or Pharma/Biotech
Minimum of 2 years experience with international trials
Experience leading a cross-functional team through all aspects of study conduct
Minimum of 2 years’ experience in CRO/vendor oversight & management
Proven clinical project management skills
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.