Clinical Research Manager

Clinical Research Manager

Clintec International

Stockholm, Sweden

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

Main Responsibilities:

  • Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) 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, company 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;
  • 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 internal stakeholders to align on key decisions in his/her studies;
  • As a customer-facing role, this position will build business relationships and represent company with investigator;
  • Shares protocol-specific information and best practices across countriesclusters.

Educational Requirements:

Required:

  • Bachelor’s degree in science (or comparable).

Preferred:

  • Advanced degree, (e.g., Master degree, MD, PhD).

Experience Requirements:

Required:

  • Strong Clinical Research Experience including previous CRA experience;
  • Previous experience in Project/Site Management;
  • Strong organizational skills with demonstrated success require;
  • Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments;
  • 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;
  • Strong leadership skills;
  • Ability to identify problems, conflicts and opportunities early and lead, analyse and prepare mitigation plans and drive conflict resolution is critical;
  • Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum noise;
  • Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other external stakeholders.

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© EuroJobsites 2018

EuroJobsites is a UK 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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