Clinical Research Manager

Location United States
Salary: £ 71000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 181
Published: about 1 month ago

Responsibilities

  • Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team
  • Responsible for project management of the assigned studies: actively plans, drive and track execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out
  • Review Monitoring Visits Reports and raise performance issues and training needs to CRA manager and/or functional vendor and internal management as needed
  • Perform Quality control visits as required
  • Lead local study teams to high performance: train in the protocol other local roles, closely collaborate with and supports CRAs as protocol guide and coordinate activities across the different local country roles ensuring a strong collaboration
  • Responsible for crafting and executing a local risk management plan for assigned studies
  • Ensure compliance with CTMS, eTMF and other key systems
  • Raises as needed different challenges and issues
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners
  • Country point of contact for programmatically outsourced trials
  • Serve local business needs as applicable in his/her country (If delegated can sign contracts and run budgets)
  • Collaborate internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies
  • As a customer-facing role, this position will build business relationships and represent the company with investigators
  • Share protocol-specific information and standard methodologies across countries\clusters

Education/Qualifications:
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution