Company: CK Clinical
Closing Date: 03 Nov 16
Salary (£): Negotiable
Charlene Dutchman is recruiting for Senior Manager, Clinical Operations to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, permanent...
Charlene Dutchman is recruiting for Senior Manager, Clinical Operations to join a leading Pharmaceutical company based in Hertfordshire, to work on a full time, permanent basis.
As a Senior Manager, Clinical Operations you will leads the cross-functional study team in managing one or more clinical studies in Oncology, ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures. Manages performance of assigned direct report(s).
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.
- Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures.
- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments.
- Called upon to develop solutions utilizing creativity and ingenuity.
- 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 study budget - for large, global or multiple regional studies.
- Coordinates all operational clinical research activities for regional / global studies.
- Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines.
- Contributes to preparation of teams and documents for inspections.
- Assesses risks and develops creative solutions.
- Supports the timely development and / or review of all study related documents (e.g., PCS, Protocol, CRF etc.) and operational feasibility assessments.
- Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
- Selects / approves monitoring CROs and study sites.
- Evaluates vendor proposals against company terms and critical needs and partners with internal functions to define scope of work.
- Manages CROs for successful conduct of the clinical trial and assesses contractual deliverables.
- Collects and reviews key monitoring processes to be benchmarked, tracked and analysed.
- Participates in cross-functional process improvement projects.
- Financial management.
- May support employees by providing input into recruitment, selection, performance, succession, and transition activities.
- Trains team members on processes and / or systems.
As a Senior 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 leading cross functional teams, people coordination, mentoring of junior colleagues.
- Experience in Onology indications is preferable.
- Experience of CRO and technical vendor management essential to ensure delivery of complex multi-national outsourced studies to time and budget.
- Full understanding of current ICH/GCP guidelines.
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 CL37269 in all correspondence.
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