Clinical Operations Manager - Oncology
Charlene Dutchman at CK Clinical is recruiting for a Manager, Clinical Operations, to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, permanent basis.
As a Manager, Clinical Operations you will manage one or more clinical studies within Oncology, to ensure that study milestones and deliverables are achieved according to agreed quality standards and timelines, and to ensure that quality of data is acceptable and suitable for regulatory submission. You will ensure that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures.
Key Accountabilities/Responsibilities will include the following:
- Setting objectives, delivering results, and implementing policies and operational targets that have a direct impact on the work unit or operational outcome.
- Presenting concepts, facts, and reporting 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.
- Having primary accountability for operational study level time, cost and quality deliverables.
- Managing overall budget for a regional or smaller study (e.g. Ph II).
- Independently overseeing all operational clinical research activities for a study or series of small studies.
- Overseeing execution of studies according to ICH / GCP guidelines.
- Contributing to inspection preparations.
- May undertake co-monitoring activities.
- Contributing to the development and/ or review of high level study related documents (e.g., PCS, Protocol, CRF etc.).
- Overseeing the development of study manuals and monitoring manuals.
- Serving as first point of contact to CROs and/ or study sites for regional or smaller study (e.g., Ph II).
- Evaluating vendor proposals against company terms and critical needs and partnering with internal functions to define scope of work.
- Monitoring and assessing vendor performance against contractual operational deliverables.
- Monitoring progress of sites/ CROs/ vendors against requirements and leading discussion of current status and resolution of issues.
- Making recommendations for improving resources (tools, systems, vendors, etc.) needed by the team.
- Managing 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 a 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.
For more information or to apply for this position, please contact Charlene Dutchman on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
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 CL33821 in all correspondence