Clinical Research Manager

1 dzień temu

Warszawa, Mazovia, Polska CDS Fortrea Inc. Pełny etat
Transform Clinical Trials with CDS Fortrea Inc.

As a leading global contract research organization (CRO), CDS Fortrea Inc. provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, CDS Fortrea Inc. is transforming drug and device development for partners and patients across the globe.

Key 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
Requirements:
  • University degree (life science), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
  • Previous experience in clinical research in pharmaceutical or CRO industries
  • Previous experience in managing trials preferred
  • Deep understanding of local regulatory environment
  • Strong understanding of clinical trial planning, management and metrics is important as well as the ability to focus on multiple deliverables and protocols at a time
  • Ability and skills to lead resource allocation, processes (and controls), productivity, quality and project delivery
  • Strong organizational skills and time management skills
  • Excellent interpersonal skills
  • Proficiency in written and spoken English and Polish

CDS Fortrea Inc. is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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