Previous Job
Previous
Associate Study Manager
Ref No.: 18-14747
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 10/22/2018 to 10/19/2019
Sunrise System Inc. is currently looking for Senior Clinical Trial Manager in Summit, NJ with one of our top client.
Job Title: Senior Clinical Trial Manager
Job Id: 18-14747
Location: Summit, NJ 07901
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Summary/Scope
  • The Sr. Clinical Trial Manager 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/guidelines, and applicable SOPs/WPs.
  • Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.
  • Responsibilities involve a combination of execution and oversight—dependent on the sourcing model — to ensure deliverables and may include, but are not limited to, the following:
  • Financial Planning and Management:
  • Development/management/reconciliation of overall study budget(s)
  • Development/management of vendor scope of work (SOW) per contract, quality, and budget
  • Review/approval of vendor invoices and management of accruals and SOW changes. 
Project Management
  • 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.
  • Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation.
  • 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 investigational product [IP]supply forecasting/management and study-level IP reconciliation [in collaboration with IMSC]
  • Development of the subject recruitment/retention strategy and related initiatives
  • 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 study training for study team, investigational sites, and vendors
  • Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
  • Participation in Serious Adverse Event (SAE)reconciliation process.
  • Experience with data cleaning and database closure coordination. 
Relationship Management
  • Development/maintenance of collaborative relationships with:
  • internal partners/stakeholders including Clinical Research, Project Management, CR&D Operations, and Affiliates external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers.
  • CTMS / EDC/eTMF 
Contact
Vishal Tejaswi
Desk:732- 272 -0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com