Project Manager - Gen Med

Novotech; United Kingdom; Remote; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing development programs

Job summary

Novotech is seeking an experienced Project Manager to lead global clinical trials from feasibility to close-out. You will be the primary contact for sponsors, overseeing planning, execution and budgeting while ensuring compliance with ICH-GCP and Novotech SOPs.

You will manage cross-functional teams across Clinical Operations, Regulatory, Medical, Biostatistics, Data Management and Vendors, with a focus on delivering on time, within budget and to high quality standards in a remote UK setting.

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• Minimum 5 years' experience in the clinical research industry.
• Strong understanding of the complete clinical trial lifecycle from feasibility through study close-out.
• Comprehensive knowledge of ICH-GCP, global clinical trial regulations and regulatory requirements.
• Proven experience managing global cross-functional clinical teams.

Responsibilities

• Lead the end-to-end delivery of assigned clinical studies from feasibility and site selection through study close-out.
• Review project scope, timelines, deliverables and responsibilities to ensure successful project execution.
• Develop, maintain and monitor project plans, study timelines, risk registers, CTMS and study tracking tools.
• Identify project risks and implement effective mitigation and contingency plans.
• Coordinate global cross-functional teams including Clinical Operations, Regulatory Affairs, Medical, Biometrics, Data Management, Pharmacovigilance and Vendor Management.
• Oversee project start-up activities and ensure study teams are trained on protocol and project requirements.
• Collaborate with Resource Management to ensure projects are appropriately staffed.
• Monitor study progress and communicate updates, risks and milestones to sponsors and leadership.
• Manage project budgets and monitor revenue forecasts and profitability.
• Escalate financial or operational risks and manage change orders with Business Development.
• Oversee vendor performance including Central Laboratories, Drug Distribution, IRT/IWRS, and other providers.

Skills

Leadership

Stakeholder management

Project management

Communication

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

5+ years in clinical research

Tools

CTMS

eTMF

Regulatory systems

Job description

Project Manager - Clinical Operations (Remote, UK)

About the Role

Novotech is seeking an experienced Project Manager to lead the successful delivery of global clinical trials from study start-up through study close-out.

As the primary point of contact for sponsors, you will be responsible for the planning, execution and management of all contracted project responsibilities, ensuring studies are delivered on time, within budget and in compliance with ICH-GCP, applicable regulatory requirements and Novotech SOPs.

You will lead cross-functional project teams, oversee study operations and financial performance, proactively manage project risks, and build strong relationships with sponsors and key stakeholders throughout the project lifecycle.

Key Responsibilities

Project Leadership & Delivery

• Lead the end-to-end delivery of assigned clinical studies from feasibility and site selection through study close-out.
• Determine project feasibility and provide operational input to support Business Development activities.
• Review project scope, timelines, deliverables and responsibilities to ensure successful project execution.
• Ensure all contracted services are delivered in accordance with the Project Agreement and agreed quality standards.
• Develop, maintain and monitor project plans, study timelines, risk registers, CTMS and study tracking tools.
• Identify project risks and implement effective mitigation and contingency plans.
• Coordinate global cross-functional teams including Clinical Operations, Regulatory Affairs, Medical, Biometrics, Data Management, Pharmacovigilance and Vendor Management.
• Oversee project start-up activities and ensure study teams are appropriately trained on protocol and project requirements.
• Collaborate with Resource Management to ensure projects are appropriately staffed throughout the study lifecycle.
• Lead, motivate and support internal project teams to deliver study milestones within agreed timelines.
• Delegate activities appropriately to Associate Project Managers while providing ongoing coaching and oversight.
• Monitor study progress and communicate updates, risks and key milestones to sponsors and internal leadership.
• Manage project budgets in accordance with the Master Services Agreement and Project Agreement.
• Monitor revenue forecasts, profitability and project financial performance.
• Identify scope changes and work collaboratively with Business Development to prepare and manage change orders before additional work commences.
• Escalate financial or operational risks that may impact project delivery or profitability.
• Work closely with Vendor Management to select, appoint and oversee external vendors including:
  • Central Laboratories
  • Drug Distribution providers
  • IRT/IWRS vendors
  • Other specialist clinical service providers
• Ensure vendor performance, quality and timelines meet study requirements.

Site & Clinical Study Management

• Identify and evaluate investigational sites to meet sponsor objectives.
• Partner with Clinical Operations and Regulatory teams to ensure timely ethics and regulatory submissions and approvals.
• Ensure investigational site personnel receive appropriate protocol and study training.
• Organise and participate in Investigator Meetings where required.
• Oversee study logistics to ensure investigational sites maintain appropriate study supplies.
• Monitor site activation, recruitment and retention performance.
• Develop and implement recruitment recovery plans where enrolment targets are at risk.
• Review monitoring visit reports to ensure protocol compliance, consistency of monitoring activities and timely issue resolution.
• Ensure safety reporting procedures are implemented and followed.
• Support CRAs to ensure monitoring activities, eCRF completion and query resolution are completed within sponsor timelines.
• Collaborate with Data Management to ensure data quality and study milestones are achieved.
• Work alongside Pharmacovigilance teams to coordinate safety management activities and Safety Review Committee activities where applicable.

TMF, Quality & Inspection Readiness

• Ensure the Trial Master File (TMF/eTMF) is established, maintained and quality controlled throughout the study.
• Review and approve essential documents required for site activation.
• Ensure Investigational Product (IP) management complies with study protocol and ICH-GCP requirements.
• Oversee study reconciliation, archiving and close-out activities.
• Maintain inspection and audit readiness throughout the project lifecycle.
• Lead responses to audits and regulatory inspections in collaboration with cross-functional teams.

Client Relationship Management

• Serve as the primary point of contact for assigned sponsors.
• Build trusted client relationships through proactive communication and delivery excellence.
• Provide regular written and verbal study updates, project reports and risk assessments.
• Lead sponsor meetings, governance meetings and project teleconferences.
• Facilitate communication between sponsors, clinical sites and internal project teams.
• Advise sponsors on local regulatory requirements and operational considerations.
• Proactively identify issues and implement appropriate mitigation strategies.
• Ensure compliance with Novotech policies, SOPs and quality standards.
• Support the review, development and implementation of SOPs and operational processes.
• Identify opportunities to improve project delivery and operational efficiency.
• Support feasibility assessments alongside Business Development.
• Identify opportunities to expand sponsor relationships and support business growth.
• Participate in Bid Defence Meetings where required.
• Represent Novotech professionally with sponsors, investigators and at industry conferences and meetings.

About You

You are an experienced clinical project leader who thrives in a fast-paced global environment. You have exceptional organisational, leadership and stakeholder management skills and are passionate about delivering high-quality clinical trials while building strong client relationships.

Qualifications & Experience

• Bachelor's degree in Life Sciences or a related discipline.
• Minimum 5 years' experience within the clinical research industry.
• Previous Clinical Project Management experience, including Associate Project Manager or equivalent.
• Strong understanding of the complete clinical trial lifecycle from feasibility through study close-out.
• Comprehensive knowledge of ICH-GCP, global clinical trial regulations and regulatory requirements.
• Proven experience managing global cross-functional clinical teams.
• Experience managing project budgets, timelines, forecasting and financial performance.
• Strong risk management and problem-solving skills.
• Excellent client-facing, communication and stakeholder management skills.
• Experience using CTMS, eTMF and other clinical trial management systems.
• Previous CRO experience.
• Experience across multiple therapeutic areas and global clinical studies.
• Experience participating in Bid Defence Meetings.
• Vendor oversight and outsourcing management experience.

We are committed to a transparent recruitment process. Where a salary range is not included in this job advertisement, shortlisted candidates will receive the applicable salary range before their first interview, in accordance with applicable local legislation.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.

Our team members are passionate about what we do, but we understand work is only of the things that is important to them.

• flexible working options
• paid parental leave for both parents
• flexible leave entitlements
• wellness programs
• ongoing development programs

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application