Clinical Project Manager/Clinical Operations Lead

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
London
Posting date: 28 Jun 2019
CR.RI.24075_1561713337

An international pharmaceutical company is seeking to recruit a Clinical Project Manager/Clinical Operations Lead to their UK team on a home-based capacity. The company specialises in end-to-end clinical and commercial solution organisation that focuses on biopharmaceutical acceleration. This is an exciting opportunity to work with a dynamic and innovative organisation that meets the needs of emerging and large global biopharmaceutical companies.

Job Responsibilities:

  • Acting as the Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT).
  • Being responsible for project management of the assigned studies: pro-actively planning, driving, and tracking execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
  • Accountable for the performance 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.
  • Reviewing Monitoring Visits Reports and escalating performance issues and training needs to CRA manager, functional vendor, and internal management as needed.
  • Performing Quality control visits as required.
  • Leading local study teams to high performance: training other local roles in protocol, closely collaborating with and supporting CRAs as protocol expert, and coordinating activities across the different local country roles ensuring a strong collaboration.
  • Creating and executing a local risk management plan for assigned studies.
  • Ensuring compliance with CTMS, eTMF, and other key systems in assigned studies.
  • Escalating as needed different challenges and issues to TA director/CRD/CQM and or CTT (as appropriate).
  • Responsible for collaborating with functional outsourcing vendors, investigators, and other external partners in assigned studies.
  • Acting as country POC for programmatically outsourced trials for assigned protocols.
  • Serving local business needs as applicable in country (If delegated can sign contracts and manage budgets).
  • Collaborating internally with HQ functions and locally with PV, Regulatory, and GMA to align on key decisions in his/her studies.
  • Building business relationships and representing the company with investigators.
  • Sharing protocol-specific information and best practices across countries\clusters.

Skills and Requirements:

  • Knowledge in Project/Site Management.
  • Previous CRA/monitoring experience.
  • 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.
  • The ability to focus on multiple deliverables and protocols simultaneously.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Reem Iskandarini at +44 203 854 2629 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-RI1

#ClinicalResearch

close