Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

The Clinical Project Manager is a key part in a product development program from concept through to commercial product. The role requires working closely with other departments in Biocomposites, including research, regulatory, quality, manufacturing, and finance. The role also requires the individual to work closely with contractors, including research laboratories and clinical research organisations.

The postholder will provide dedicated oversight of the clinical studies commissioned by Biocomposites, involving planning, organizing, and directing the activities of personnel involved in clinical research projects to make sure that they deliver in line with the clinical goals and objectives.

The Clinical Project Manager will act as the primary contact for vendors and will lead in planning and communication with diverse study teams to make sure that trials are conducted and executed effectively. They are also responsible for the preparation and review of all documents that are related to clinical projects, which includes contracts, vendor budgets, regular updates and annual reports.

Reports to

Clinical Research Director

Location & Working pattern

Wilmington, NC - Monday to Friday 9am to 5pm

Duties & Responsibilities

• Work closely with the Clinical Research Director to develop and execute the Project Plan
• Act as project Manager to ensure effective project management, providing timely issue resolution, expert knowledge and key decisions at each stage of the project
• Manage adherence to project budgets
• Report and communicate project progress on a regular basis to key stakeholders
• Provide regular reports, quantifying progress, performance, cost and associated internal risk relative to the achievement of project goals
• Establish and maintain key relationships with internal and external stakeholders
• Negotiate and Influence key stakeholders at all levels in line with business and programme requirements and ensure that productive and effective relationships are maintained
• Demonstrate creativity and innovation on projects by maintaining up to date knowledge of advances in project management techniques
• Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
• Prepare, oversee, and review documents that are related to assigned clinical study
• Ensure the availability of necessary resources for the execution of clinical projects
• Review and approve invoices being presented by study vendors and external consultants
• Answerable to questions and issues brought up by vendors and external consultants
• Fully involved in resolving issues and contribute to improvement strategies for delivery of future studies
• Work with other members of the study team to outline priorities, and resolve conflicts that may come up in the project process

Essential requirements

• A minimum of 5 years experience in the field of clinical research of which 2 years must have been in a project lead role

• Experience in writing clinical study procedures and other clinical documents

• Delivery of Site Initiation Training for clinical trials

• In depth knowledge of ICH GCP

• Able to convey information to clinical investigators, clinical trial sites and CROs

• Ability to organise and motivate other members of the study team.

• Must be able to work as part of a team.

• Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants.

• Good problem-solving, organizational, and leadership skills are highly required.

• Ability to pay keen attention to detail at all times.

• Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
• GCP training

Desirable requirements

• Medical, nursing or scientific degree

• Protocol writing

• Knowledge of IRB submissions

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.