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Associate Study Manager
Ref No.: 18-10678
Location: Summit, New Jersey
Position Type:Contract
Start Date / End Date: 08/13/2018 to 08/10/2019
Sunrise System Inc. is currently looking for Associate Study Manager in Summit, NJ with one of our top client.
Job Title: Associate Study Manager
Job Id: 18-10678
Location: Summit, NJ 07901
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Essential Experience Required:
  • Minimum 6 years’ clinical study management (study manager, study leader, clinical manager) experience at a CRO or Pharma/Biotech with at least 2 years direct multinational study management experience; experience leading a cross-functional protocol implementation team through all aspects of study conduct.
  • Minimum of 2 years' experience in oversight of CRO for clinical study execution.
  • At least 2 years’ recent experience in hematology/oncology studies
  • BA / BS or higher degree in relevant discipline 
Skills/Knowledge Required
  • Clinical trial project management skills.
  • Financial budgeting and forecasting skills.
  • Leadership / influence management skills including stakeholder management and effective communication
  • In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
  • Ability to effectively lead and direct a global cross-functional team in a matrix environment.
  • Time management skills – ability to effectively prioritize
  • Proven problem solving and decision making skills.
  • Demonstrated success in using oral and written communication skills to influence, inform, or guide others
  • Solid computer skills – requirement of MS applications including (but not limited to) MS Project,
  • Word, Excel, PowerPoint
  • Study Tools including electronic system skills – CTMS / EDC/eTMF, etc. 
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
  • Affiliates external partners including Contract Research Organizations (CROs)
  • Academic Research Organizations (AROs), and other clinical service providers. 
Contact
Praful Prasanna
Email: Praful.P@sunrisesys.com | Direct: (732) 272 0326
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com