WCCT Global has a unique process-based management approach, which helps to establish a clear vision of a project and to define the strategy, structure, and resources required to achieve success.
From the start to completion of a clinical research study, the Clinical Project Manager II will:
Ensure progress and productive interaction between the various parties and stakeholders involved in the project.
Mentor the junior-level Project Managers and assist the other Managers to ensure progress and productive interaction between the various parties and stakeholders involved in the project.
Manage clinical studies under the supervision of the Director of Project Management.
Under the supervision of the Director of Project Management or designee, duties and responsibilities may include, but will not be limited to:
Duties and Responsibilities:
With input from the WCCT Global clinical team, WCCT Global Management, and the Sponsor, establish and track clinical study milestones/timelines for the site(s); provide feedback to all parties as milestones/timelines change.
Ensure successful project start-up by facilitating processes for preparation of site(s) regulatory documents, development of clinical study/source documents, and ensuring timely IRB approvals for clinical trial materials.
Lead project meetings with clinical team and/or Sponsor as needed.
Track recruitment activities to ensure timely enrollment of studies.
Assist in tracking of lessons learned and share those lessons with fellow team members.
As needed, create or review for approval Project Plans including: Project Management Plan, Data Management Plan, Clinical Monitoring Plan, Safety Plan, CRF Completion Guidelines, and/or Statistical Analysis Plan; provide input to vendor, Sponsor, and/or WCCT Global Management.
Support and collaborate with the Medical Writer and Sponsor to ensure completion of the Clinical Study Report (CSR), as applicable.
Manage day-to-day client/Sponsor relations; communicate effectively with client to identify needs and emerging issues.
Demonstrate the ability to tactfully communicate difficult/sensitive information to the Sponsor.
Establish communication expectations and channels with Sponsor and Vendor(s) at beginning of trial; maintain these throughout the duration of the study.
Assist with site tours of WCCT Global facility, as needed.
Assist with sponsor visits including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits.
Identify and mitigate issues or risks.
Resolve and/or escalate issues in a timely fashion.
Review and manage study contracts/budgets and provide relevant budgetary limits to the appropriate departments.
Review and approve Vendor/Site contracts, budgets, and invoices.
Provide budget accrual projections to WCCT Global Management.
Collaborate with Billing and Accounts Payable to ensure sponsors are billed based upon completion of study initiatives.
As needed, assist the WCCT Global operational team by assisting with clinical floor duties.
Manage day-to-day operational aspects of a clinical trial, providing oversight and guidance to the WCCT Global clinical team.
Comply with and help enforce WCCT Global standard policies and procedures, as well as GCP/ICH Guidelines.
Perform other related duties as assigned by Supervisor and incidental to the work described herein.
Bachelor’s degree or higher, or completion of an allied health degree (e.g. Licensed Vocational Nurse) or an acceptable combination of education and trial management experience is required
Minimum of 2 years clinical research experience required
Minimum of 1 year project management experience required
Phase I or Early Phase experience preferred
CCRC certification preferred
Certified Associate in Project Management (CAMP) preferred