Clinical Operations Manager

Job title:

Clinical Operations Manager

Company

Simbec-Orion

Job description

ABOUT US:Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team.With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives. THE ROLE:We are searching for a Clinical Operations Manager to join our team. In this role, you will be responsible for managing a team of Clinical Operations employees to ensure that all departmental objectives and KPIs are met. You will also provide support and mentorship to your direct reports to ensure the execution of all clinical studies with operational excellence in mind, and to guarantee the highest quality. Additionally, you will ensure appropriate resourcing for all studies within the agreed budget, and proactively raise awareness of additional personnel needs based on departmental requirements to the Head of Department.You will be accountable for the performance of your direct reports in monitoring, ensuring the protection of subjects’ rights, safety, and well-being, as well as reliable and high-quality trial data. You will also be responsible for ensuring study timelines and milestones are met. Furthermore, you will oversee the In-House Clinical Research Associate team to ensure proper management of study start-up and necessary in-house activities throughout the study duration. Your responsibilities will also include overseeing the performance of Clinical Trial Managers, providing financial adherence to clinical studies, and ensuring the delivery of study milestones for clinical operations team members. Additionally, you will be involved in direct communication with sponsors and clients, as appropriate. You will be expected to conduct bi-weekly 1:1 meetings to discuss and document the performance of team members, fostering appropriate employee growth and development. KEY ACCOUNTABILITIES:

• Line management of Clinical Operations Employees (IHCRAs, CRAs, CTMs).
• Ensure appropriate resourcing is available for clinical studies per the agreed budget, filling vacancies within the department while providing an active role in recruitment.
• Ensure appropriate onboarding of employees, and provide training and support for all direct reports to ensure no knowledge gaps within the role are present.
• Responsible for maintaining high-quality standards across the department as set out in Simbec-Orion SOPs, ICH-GCP regulations, departmental objectives, and KPIs.
• Ensure employees maintain compliance by performing spot-checks of visit reports, completion of clinical trial systems, employee training adherence and timely (e)TMF filing.
• Responsible for reviewing and analysing metrics (e.g., departmental KPIs, productivity, audit trends) and subsequent action plans to address concerns.
• Perform Accompanied Visits with direct reports to assess performance and develop improvement plans to create a quality and continuous development culture.
• Management of administrative aspects of Line Management (Timesheets, expenses, performance reviews, etc.)
• Contribute to SOP updates and process improvements for the Clinical Operations Department.
• Contribute to departmental working groups, initiatives, training and other commitments to grow and scale the department.
• Involvement in direct communication with Sponsors and Clients, such as client calls, Bid Defence and Governance meetings where appropriate.
• Close communication and working relationships with key departments (i.e., Project Management, Medical and Regulatory Affairs, Biometrics and Quality Assurance, etc.) to ensure the smooth running of clinical studies.
• Enhance the country/regional responsibility for overall Clin Ops performance in the assigned region/country.
• Engagement with site start-up and site performance, including ensuring all study start-up aspects are properly managed, recruitment is appropriate, and devising ways to support staff to meet project milestones.

SKILLS REQUIRED:ESSENTIAL:

• Bachelor’s degree in Nursing, Life Sciences or Medical Sciences or equivalent work experience required
• Experience as a Clinical Research Associate and Clinical Trial Manager at Simbec-Orion or other CRO
• Previous Line Management / mentoring experience
• Excellent communication and presentation skills
• Expert knowledge of relevant clinical research regulations and ICH-GCP
• Ability to establish/maintain good relationships with sites/colleagues/clients
• Ability to make decisions independently / Strong problem-solving skills
• Highly developed mentoring and motivational skills

DESIRABLE:

• Advanced degree (Masters, MD, PhD)
• Previous CRO experience
• Good experience in CTMS, eTMF IXRS and EDC systems
• Experience in clinical trial planning and metrics management
• Experience in multinational trials
• Multiple therapeutic experiences

WHY YOU SHOULD JOIN US:Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company – and your reason to be a part of it.With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.

Expected salary

Location

United Kingdom

Job date

Sat, 12 Oct 2024 07:20:16 GMT

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