Current Opportunities

Return to jobs

Clinical Operations Contractor

Industry: Life Sciences

Apply for this position

Clinical Operations Contractor - NJ
 
My client is a global biopharmaceutical company located in Southern New Jersey. They have 12 products in the pipeline and 3 marketed products. They are looking for a clinical operations contract employee.

Contractor – Clinical Operations

POSITION SUMMARY

The contractor will be responsible for the successful execution of a protocol in North America (NA) and Latin America (LA) from study start up to archiving of the regulatory documents; interact with the operations team to ensure timelines, deliverables, and data quality are met within budget for NA and LA; handle multiple competing priorities and utilize resources effectively; and provide mentoring guidance, coaching, and feedback to the team.

NA and LA Study Team Level:

  • Lead NA and LA regular monitor meetings
  • Core member of Global Operations Team
  • Liaising with LRM for protocol specific activities
  • Provide protocol specific training and guidance to internal operation team
  • Develop, review, and/or provide input into study documents (e.g., monitoring guidelines, CRF instructions, and study budget template)
  • Accountable for facilitating, tracking, and monitoring the progress of study activities
  • Plan, set-up, and manage the NA and LA trial communication plan, including investigator, monitor, and operational team meeting schedules, overall drug supply, and management and provision of other study materials in accordance with project and study level plans
  • Manage/execute NA and LA operations activities including, but not limited to country/site feasibility, investigator meeting planning, study and site start up, site management, database lock activities, site closure and TMF archiving
  • Manage the NA and LA regulatory document approval process
  • Ensure timely finalization of contracts (could include budget negotiation)
  • Manage investigator payments and invoices
  • Liaise with cross-functional groups to obtain necessary documents/information from sites or RMs (e.g. obtaining lab normal ranges for Data Management, drug re-supply notification to CTSM, SAE reconciliation/query resolutions for Drug Safety)
  • Manage vendor activities for NA and LA (e.g., CROs, Central Labs, IVRS)
  • Ensure the third party contracts and investigator budgets are executed
  • Manage the TMF set-up with Central Document Management (CDM), review key documents for approval and perform quality checks to ensure the appropriate filing of documents by CDM
  • Provide relevant study documentation for global audit plans and ensure that corrective actions are implemented in response to audit findings and communicate findings to CTPM/COPL
  • Initiate improvements to enhance the efficiency and the quality of deliverables
  • Coach and provide feedback to junior team members on project specific issues and contribute to the establishment of best practices
  • Provide feedback to line manager on team member performance
  • Act as a mentor and subject matter expert for team members
  • Lead or participate in initiatives and/or task forces

Required Qualifications

  • Bachelor of Science degree in a biological science or healthcare profession
  • At least four years of clinical research experience
  • Management of local/less complex studies (e.g. Phase II, small Phase III/IIIb studies, open label studies)
  • Monitoring experience required
  • Understanding of the drug development process
  • Understanding of ICH guidelines and GCP

Location:

  • Philadelphia, PA
  • Princeton, NJ 

If you meet the above criteria and would like to learn more, please forward a word document of your resume to lbrantz@kleinhersh.com. For other openings in the life science industry, visit our website at www.kleinhersh.com

For additional information about this job, please contact: lbrantz@kleinhersh.com