Reference Number: JO-2103-464109
Clinical Study Lead (IVD)
Job Type: Permanent
Clinical Study Lead IVD
Competitive Salary + Benefits
A leading biotechnology business are looking for an experienced Clinical Study Lead to be a pivotal member of the core project team based at their Manchester site. You will play a decisive part in the launch of new products or development of established products. You will be joining an innovative, global business who place their staff as their most valuable asset.
The successful applicant will be responsible for the design, planning and conduct of clinical studies, including reporting results. You will lead/oversee the activities of cross-functional teams and external stakeholders to ensure compliance with organizational SOPs and all global regulations, while studies are delivered on time and on budget.
– Responsible for study design, strategy, planning (timeline, required resources and
– Development and execution of all study associated documentation including protocols,
investigator brochure, informed consent, contracts, and reports, in compliance with
relevant regulations, guidelines and SOPs.
– Accountability for all ethics & regulatory submissions
– Tracking and reporting of study delivery milestones
– Project-specific training of CRAs
– Arranging and overseeing site visits. Accountable for managing site auditing or QC visits
where necessary to address or improve quality.
– Accountable for study close out procedures and working with CTAs, CRAs and Data /
Statistic stakeholders for close-out documents and reviews.
– Previous study management/leadership experience with a small pharma, medical device
or diagnostic company
– Understanding of Electronic Data Capture (eDC), eTMF and CTMS or similar clinical
– Authoring clinical study documents e.g. Protocols, Investigator Brochure, Informed
– Strong understanding of the in vitro diagnostic industry including product design controls
and development processes (ISO13485), CLSI guidance, and ICH good clinical practice.
– Life Science Degree
The successful applicant will be rewarded with a competitive salary and benefits. You will have home working flexibility but will be required to be on site 2-3 days per week. If this role is of interest, please send your CV to George.Danchie@cpl.com or call 0118 959 4990