Effective Project Managers are essential for managing the study team and meeting project time-lines.  Clinique Research Services, Inc. provides full project management support by assigning a Clinical Project Manger to communicate and manage all study activities.  There are 75% of Clinique Research Services, Inc. consultants which have project management experience from previously held industry positions.

 

Clinical Research Project Manager Tasks:

 

• Contract Negotiation

Clinique Research Services Inc. provides complete contract negotiation, that include but are not limited to; site negotiation, payment for services & consulting outsourcing for the conduct of clinical trials.

• Contract Management

Clinique Research Services, Inc. provides tracking, oversight and execution of contract/grant payments to clinical research sites and outside consultants.

Outsourcing Management

Clinique Research Services, Inc. will maintain and execute oversight and management of contractors including CRO’s, central laboratories and independent consultants.

Timeline Tracking

Clinique Research Services, Inc. will identify and assist clients in establishing and maintaining study milestones and deadlines throughout the conduct of the clinical trial.

Trip Report Review and Submission

Clinique Research Services, Inc. will collect, review and submit monitoring visit documentation and assume the responsibility for submission to the client.

Quality Assurance Program

Clinique Research Services, Inc. has designed and implemented a proprietary “Monitor the Monitor” program. Clinical Research Project Managers audit previously monitored research to ensure quality monitoring and adherence to company standard operating procedures.

Regulatory Services

  • Regulatory submissions to Ministry of Health and Ethics committee for Clinical Trial Approval.
  • Inspection readiness preparing the site or sponsor for regulatory inspections