Senior Clinical Study Manager

Cycle Pharmaceuticals; Town of Cambridge; Hybrid; AUD 133,000 - 208,000; Full time

Benefits offered by this job

Competitive salary based on experience

Performance based bonus

Company pension scheme

Private Health Insurance

Life and Critical Illness Insurance

Regular team building events

Job summary

Cycle Pharmaceuticals is seeking a Senior Clinical Study Manager to lead the operational delivery of Phase 3 trials and Phase 4 post-approval studies across rare diseases from feasibility to final report. The role reports to the Associate Director of Clinical Operations and requires oversight of timelines, budgets, quality and regulatory compliance.

You will own studies, coordinate site selection, supply planning, and DMC activities while collaborating with cross-functional teams.

Qualifications

• Degree in life sciences, pharmacy or a related discipline required; an advanced degree is preferred.
• Significant clinical operations experience within pharma/biotech/CRO, including Phase 3 leadership.
• Experience delivering studies in rare diseases, metabolic conditions or paediatric populations is strongly preferred.
• Experience managing post-approval studies, FDA post-marketing requirements, registries or observational studies is strongly preferred.
• Strong experience with US clinical sites and FDA requirements is an advantage.

Responsibilities

• Deliver Phase 3 studies from feasibility to database lock and final report, managing timelines, budgets, risks and quality.
• Lead feasibility, country/site selection and recruitment/retention strategies incl. decentralised approaches.
• Coordinate clinical supply planning, randomisation, interim analyses and DMC activities with cross-functional teams.
• Support post-approval studies, FDA post-marketing requirements, registries or observational studies to meet milestones.
• Oversee CROs/vendors, manage budgets and monitor KPIs and spend.
• Ensure compliance with GCP/regulatory submissions, eTMF maintenance, audits and CAPA follow-up.
• Build relationships with investigators, centres and patient advocacy groups.
• Identify operational risks and implement corrective actions; contribute to budget/resource planning.
• Share best practices and mentor colleagues, with potential line management responsibilities.

Skills

Phase 3 trials

Clinical operations

Regulatory compliance

Vendor management

Clinical supply planning

Budget management

Stakeholder management

Travel flexibility

Education

Bachelor in life sciences or pharmacy

Advanced degree preferred

Tools

eTMF systems

CTMS / trial management systems

Job description

Position Summary: This full-time position is within the Research and Development department in our Cambridge office on a hybrid basis (minimum 3 days in the office).

Do you want to make a meaningful difference in rare disease research?

At Cycle Pharmaceuticals, we’re expanding our Research and Development team and now recruiting for a hands-on Senior Clinical Study Manager to manage the operational delivery of Phase 3 clinical trials and Phase 4 post-approval studies across rare diseases, including studies undertaken to meet FDA post-marketing requirements and commitments.

Reporting to the Associate Director of Clinical Operations, you’ll take ownership of assigned studies from feasibility through to final clinical study report, ensuring delivery to agreed timelines, budgets and the highest standards of quality and regulatory compliance.

This is an opportunity to take on broad responsibility in a growing organisation, combining independent ownership, cross-functional collaboration and the opportunity to help advance research in rare diseases.

Our Company

At Cycle, we believe that Every Single Patient Matters. This is at the heart of why we work and were looking for people to join our team who share our vision. We know that life-changing treatments need life-improving product support to match, because when you put the two together, great things can happen.

Our growing portfolio now covers oncology, haematology, neurology and rare metabolic genetic conditions where we improve existing drugs, repurpose them for new uses and bring generics back to market. Using cutting-edge drug delivery technologies, we enhance the efficiency of treatments, offering patients greater freedom and choice.

Headquartered in Cambridge, UK, with a significant US presence, Cycle has scaled rapidly and was named one of the UK’s fastest-growing private companies by The Sunday Times (Sunday Times 100 2024 & Sunday Times 100 Tech 2025). If you want to know more about what we do then, why not check out our website and take a look at some of our patient stories: Patient Stories - Cycle Pharma

What you’ll be doing in this role:

• Delivery of assigned Phase 3 clinical studies from feasibility through to database lock and final clinical study report, managing timelines, budgets, risks and quality.
• Lead feasibility, country and site selection and develop recruitment and retention strategies tailored to small and pediatric populations, including patient-centric and decentralised approaches where appropriate.
• Coordinate clinical supply planning, randomisation, interim analyses, data monitoring committee activities and adaptive design decision points in collaboration with relevant teams.
• Support with operational delivery of post-approval studies, including FDA post-marketing requirements and commitments, registries, observational studies, real-world evidence and open-label extensions, ensuring key regulatory milestones are met.
• Support partner selection and contracting and vendor performance, monitor KPIs and study expenditure.
• Ensure studies comply with applicable GCP and regulatory requirements, oversee regulatory and ethics submissions, maintain the electronic Trial Master File (eTMF), and support audits, inspections and CAPA follow-up.
• Build effective relationships with investigators, specialist centres and patient advocacy groups.
• Proactively identify and mitigate operational risks and issues, escalating significant concerns and implementing appropriate corrective actions.
• Contribute to departmental budget planning, resource forecasting and prioritisation to support clinical operations strategy and efficient study delivery.
• Improve clinical operations processes and procedures, share best practice, and mentor and support clinical operations colleagues, with potential for future line management responsibilities.

The following skills and experience will be important in helping to set you up to succeed in this role:

• Degree in life sciences, pharmacy or a related discipline required; an advanced degree is preferred.
• Significant clinical operations experience within the pharmaceutical, biotechnology or CRO industry, including operational leadership of Phase 3 clinical studies.
• Experience delivering studies in rare diseases, metabolic conditions or paediatric populations is strongly preferred.
• Experience managing post-approval studies, including FDA post-marketing requirement and commitment studies, open-label extensions, registries or observational studies, is strongly preferred.
• Strong experience working with US clinical sites and FDA requirements and familiarity with FDA Bioresearch Monitoring inspections is an advantage.
• Proven ability to oversee CROs and vendors, manage study budgets and maintain high-quality electronic Trial Master Files (eTMFs).
• Experience with hybrid or decentralised trial approaches, including home nursing and direct-to-patient supply, is desirable.
• Strong working knowledge of ICH-GCP, including E6(R3), and applicable FDA, MHRA and EMA requirements.
• Excellent organisational, analytical and project management skills, with the ability to manage competing priorities, solve problems independently and drive delivery.
• Strong communication and stakeholder management skills, with the confidence to work effectively across cross-functional teams and external partners.
• Proactive, hands-on and decisive, with a practical, solutions-focused mindset and a willingness to travel, including internationally to the US.

What can we offer to you:

In addition to being part of a great team and doing things that will make a real difference to patients’ lives, you will enjoy all the benefits that brings:

• Competitive salary based on experience
• A collaborative high performing work environment
• Performance based bonus
• Opportunity to join a fast growing and ambitious business
• Company pension scheme
• 100% employer paid membership for Private Health Insurance
• Life and Critical Illness Insurance
• Regular team building events and an agile working environment

Diversity and Inclusion statement:

At Cycle Pharmaceuticals, we are committed to creating an inclusive, respectful, positive and diverse workplace. We do not discriminate on the basis of race, colour, religion, gender, age, disability, or any other protected characteristic. We actively support and embrace diversity, and we are working to build a team that reflects a wide range of backgrounds and perspectives.

We value your unique contributions and encourage you to join us in shaping a more inclusive future. If you require any reasonable adjustments - whether during the application process or in the workplace - we will be happy to support your needs. At Cycle, equality, inclusion, and respect are at the core of everything we do. We fully comply with all applicable employment laws, including those related to non-discrimination, work authorization, and employment eligibility verification.