We have an exciting opportunity available for an experienced Clinical Study Manager who will support our client’s Surgical Business Unit.

Our client is a world-leading developer and manufacturer of wound care and surgical products.

The position will be home-based (anywhere in the UK or across Europe). However, regular travelling across sites when needed will be required.

The successful candidate will be responsible for managing clinical studies, ensuring that investigators conduct research within the requirements of the clinical protocol, and in accordance with applicable regulations.

Clinical programmes include clinical investigations to support the approval of new devices, as well as PMCF studies for their established world-class products.

Previous experience in clinical research within the medical device sector (Class 3 medical devices) and knowledge of the regulations governing clinical studies is required.

We would welcome the opportunity to connect and provide further details if you feel this is the right role for you!

Minimum Requirements:

• Bachelor’s degree in life sciences or health-related field or equivalent education and experience
• Minimum of 5 years’ experience as a Clinical Research Associate, Clinical Project Manager or in a similar capacity
• Experience within the medical devices industry
• Knowledge of regulations and guidance governing clinical studies including 21 CFR 812, 50, and 56, ICH GCP, HIPAA, and ISO 14155
• Advanced level of computer literacy: MS Office Suite
• Solid organisational skills
• Ability to work under pressure to meet with company requirements (process/project time frames, regulatory requirements)
• Ability to influence and challenge others in a constructive way to deliver improvements.
• Ability to travel up to 25%. (National and International)

Responsibilities will include:

• Identification of study sites and investigators.
• Management and oversight of clinical monitoring activities, including review and approval of visit reports.
• Management of Contract Research Organisations and other vendors, including oversight of delegated activities.
• Oversight of study budget, including invoicing and payments.
• Development of clinical study documentation including protocol, investigator’s brochure, case report form and consent documents.
• Development of study-specific plans including project management plan, clinical monitoring plan, data management plan, safety plan etc.
• Preparation and submission of documents for Institutional Review Board / Ethics Committee approvals and amendments.
• Oversight of site initiation, site management, and close-out activities.
• Monitor enrolment rate and implement strategies to mitigate risk to study timelines.
• Oversight of the Sponsor’s Trial Master File (creation and maintenance).
• Management of study timelines.
• Preparation of clinical study reports and communication of study results to internal and external stakeholders.
• Ensure compliance with AMS SOPs, GCP, and all applicable regulations, standards, policies and guidelines related to clinical research, clinical trials, and interactions with physicians.
• Provide clinical input for the product development process including regulatory submissions, marketing material, and risk documentation.
• Management of vendors executing PMCF surveys.
• Preparation and/or review of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and PMCF Plans