Clinical Research Manager

2 tygodni temu

Warszawa, Mazovia, Polska Pharmiweb Pełny etat
Role Summary

As a leading contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, we provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in more than 90 countries, we are 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
  • Raise 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


As an EOE/AA employer, we strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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