Company: CK Clinical
Closing Date: 03 Nov 16
Salary (£): Negotiable
Charlene Dutchman is recruiting for a Manager, Clinical Operations, to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, fixed...
Charlene Dutchman is recruiting for a Manager, Clinical Operations, to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, fixed term basis for 12 months initially.
As a Manager, Clinical Operations you will be the EU regional lead for 2-3 studies for a global, phase 3 Neurology programme, which comprises 4 studies in start-up/maintenance. The role will typically entail liaising with internal functions, regional management of CRO/vendors to ensure optimal study/site start-up, optimal regional recruitment and facilitation of local operational budgetary and logistical issues.
Key Accountabilities/Responsibilities will include the following:
- Sets objectives, delivers results, and implements policies and operational targets that have a direct impact on the work unit or operational outcome.
- Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues.
- Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity.
- Has primary accountability for operational study level time, cost and quality deliverables.
- Manages overall budget for a regional or smaller study (e.g. Ph II).
- Independently oversees all operational clinical research activities for a study or series of small studies.
- Oversees execution of studies according to ICH / GCP guidelines.
- Contributes to inspection preparations .
- May undertake co-monitoring activities.
- Contributes to the development and/ or review of high level study related documents (e.g., PCS, Protocol, CRF etc.).
- Oversees the development of study manuals and monitoring manuals.
- Serves as first point of contact to CROs and/ or study sites for regional or smaller study (e.g., Ph II).
- Evaluates vendor proposals against company terms and critical needs and partners with internal functions to define scope of work.
- Monitors and assesses vendor performance against contractual operational deliverables.
- Monitors progress of sites/ CROs/ vendors against requirements and leads discussion of current status and resolution of issues.
- Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team.
- Manages the workflow of others to ensure work is done within a given deadline.
- May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
As a Manager, Clinical Operations, you will have the following qualifications, skills and experience:
- BS/MS in relevant field.
- Experience in clinical operations methods and processes in industry setting required.
- Proven track record of coordinating international study teams, including CRO/vendor management and internal cross-functional collaborations to deliver high quality Oncology studies.
- Full understanding of current ICH/GCP guidelines.
- Previous oncology experience, including awareness of current anti-tumour therapies, and be at ease with tools such as RECIST criteria for tumour assessment, NCI Common Toxicity Criteria.
CK Clinical 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 CL37250 in all correspondence
9 High Street
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