Clinical Research Manager

Clinical Research Manager

Syneos Health

Netherlands

We are currently looking for a Clinical Research Manager to strengthen our team in The Netherlands. This role is within our FSP department and you will be fully outsourced to one of our clients, a major pharmaceutical company based in Haarlem.

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The CRM could be responsible for a particular study for several countries in a cluster.

The main responsibilities include:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT);
  • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out;
  • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally;
    • Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed;
    • Performs Quality control visits as required.
  • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration;
  • Responsible for creating and executing a local risk management plan for assigned studies;
  • Ensures compliance with CTMS, eTMF and other key systems in assigned studies;
  • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate);
  • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies;
  • Country POC for programmatically outsourced trials for assigned protocols.;
  • Serves local business needs as applicable in his/her country(If delegated can sign contracts and manage budgets);
  • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed;
  • As a customer-facing role, this position will build business relationships and represent the company with investigators;
  • Shares protocol-specific information and best practices across countriesclusters.

We are looking for enthusiastic candidates with the following:

  • Knowledge in Project Management and site management;
  • Strong organizational skills;
  • Requires strong understanding of local regulatory environment;
  • Strong scientific and clinical research knowledge is required;
  • Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously;
  • 5-6 years of experience in clinical research of which at least 3 as CRA;
  • Advanced degree, (e.g., Master degree, MD, PhD).

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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