Job Description

Company:

PellePharm

Role Title:

Clinical Trial Manager

Reports To:

VP of ClinOps

Job Description:

The Clinical Trial Manager (CTM) will be responsible for the day-to-day operational oversight of one or more clinical trials including trial start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. They may oversee and direct the functions of in-house and regional CRAs to provide monitoring guidance, training and oversight. This role will support the Senior CTM who will be responsible for the overall study oversight.

The CTM will also provide oversight of the CRO and other third-party vendors on the assigned study where applicable. The CTM will ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.

The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.

Responsibilities:

  • Support Vendor selection and on-boarding of multiple vendors including but not limited to patient recruitment/retention vendor, messaging/branding vendor, central and other specialty Labs. This will include:
    • Support contract and budget completion
    • Ensure vendor timeline is accurate and oversee vendor activities
    • Oversee CRO management of CRO vendors
    • Provide guidance on study conduct for each vendor
    • Manage/oversee set-up and testing of CRO vendors such as IXRS, Central Lab
    • Review CVs and approve qualified vendor staff
    • Attend and contribute to regular team and vendor meetings/calls
    • Provide meeting minutes as applicable and review meeting minutes
    • Assist with material development
    • Review and track regular vendor invoices
  • Support site selection and study-start up activities
    • Support the process of identifying and selecting clinical trial sites
    • Assist in creation of feasibility questionnaires and other documents related to site feasibility and selection
  • Prepare and assist with study management plans and tracking
    • Assist with the preparation of other key internal plans/documents including but not limited to study responsibility grid, communication plan, issue escalation plan, site activation plan, risk assessment/mitigation plan, vendor management plan, quality management plan
  • Prepare study tracking tools and track study enrollment
    • Assess/review CRO monitoring quality
    • Oversee regional monitors (CRAs)
    • Review MVRs (trip reports) and assess CRO monitoring quality based on Pelle Pharm Vendor management plan, protocol, and GCP
    • Perform co-monitoring visit in NA (or delegate to CRA)
    • Attend as needed SIV and assist with site training
  • Prepare study tracking tools and track study enrollment
    • Ensures timely sites’ submission to central or local IRB/IEC
    • Track/monitor CRF completion, queries by review of study metrics, IP dispensing and compliance by IXR and CRF (vendor) report review in coordination with CDM
    • If required, assist with the collection of safety information for internal review
  • Assist with review of site invoices and correlate with site completed subject visits/CRF completion and site data quality
    • Site Payment Review
    • Authorize payments
    • Track site spend and other vendor spend/invoices
    • Alert management of need for Change Orders (C/Os)
    • Work with finance to report monthly spend
  • Assist with the planning and conduction of Investigator meetings/DSMB
  • Support Senior CTM in the preparation of internal and external study/project team meeting minutes
  • Assist the Senior CTM as needed
  • Mentor junior staff

Requirements:

  • BA/BS or equivalent degree in scientific discipline
  • Working knowledge of GCP/ICH guidelines and the clinical development process
  • Minimum 5 years of clinical trial management experience in biotech
  • 2-3 years as a Senior CRA
  • Experience in managing outside vendors, e.g. CROs and other vendors
  • Experience with U.S. and preferred Ex-U.S. clinical trial management and Regulatory processes
  • Previous experience working with an electronic Data Capture System (eDC)
  • Previous experience working with eTMF and CTMS systems desired
  • Proficient with MS Word, Excel and PowerPoint. Experience with MS Project or similar software is a plus
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Able to solve problems under pressure
  • Able and willing to travel domestically for site visits, IMs as applicable

1

  • Accepted file types: pdf, doc, docx.
  • This field is for validation purposes and should be left unchanged.