CK Group is recruiting for a Clinical Research Manager to join a company in the Pharmaceutical industry at their site based in Central London on a contract basis for 12 months initially.
The role is based from home although involves 30% travel to sites across the UK and Ireland, as we ask for 2 days per month in the office in Central London.
This role is primarily accountable for the end to end 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. The CRM could be responsible for a particular study for several countries in a cluster.
• 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, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
o 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
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
• Knowledge in Project/Site Management.
• Requires strong understanding of local regulatory environment
• Previous experience working as a CRA
• Extensive clinical trial management experience
• Willingness to travel
• Experience in Oncology and Paediatrics would be preferable but are not essential
For more information or to apply for this position, please contact Lucy Stendall on 01246 457733 or email firstname.lastname@example.org. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42708 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: KA42708
- Posted: 5th July 2018
- Expires: 2nd August 2018