Clinical Trial Manager

Astellas Pharma; Addlestone; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A progressive health organization in the UK is looking for a Clinical Trial Manager to oversee oncology trials. This role involves managing operations, leading cross-functional teams, and ensuring compliance with regulatory requirements. The ideal candidate must possess a strong background in oncology and demonstrate leadership capabilities. The position offers a hybrid working model, requiring both office and remote work to ensure work-life balance while supporting innovative health solutions.

Qualifications

• Demonstrated experience in Oncology therapeutic area is essential.
• Proven experience with globally conducted trials, including setup.
• Strong vendor management capabilities to coordinate external partners.

Responsibilities

• Manage operations of assigned trials ensuring goal completion.
• Lead cross-functional trial teams, including vendors.
• Provide regular updates of trial progression to stakeholders.
• Proactively identify and resolve issues during trial conduct.
• Develop core trial documents and ensure operational excellence.

Skills

Oncology experience

Global trial expertise

Vendor management

Cohort management

Project management

Interpersonal communication

English proficiency

Education

BA/BS degree with clinical trial experience

Advanced degree (MS/PhD/PharmD)

Job description

Description

Clinical Trial Manager (Oncology) – UK

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity

In this role you will be responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include : pre / post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

Be accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOP’s and standards to ensure quality of trial deliverables.

Hybrid Working

At Astellas we recognize the importance of work / life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Key Activities For This Role

• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP / ICH guidelines and other regulatory requirements.
• Lead or support cross-functional trial teams, including vendors.
• Ensure accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
• Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational. excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
• Participate in or facilitates site engagement and communications with investigators and / or staff to support trial milestones and deliverables.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
• Provide oversight and direction to trial team members for trial deliverables.
• Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems.
• Ensure quality and completeness of TMF for assigned clinical trials.
• Participate in inspection readiness activities including coordination of clinical trial team deliverables.
• Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
• Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.

Essential Knowledge & Experience

• Experience in Oncology : demonstrated current or previous experience within the Oncology therapeutic area is essential.
• Global Trial Expertise : proven experience working on globally conducted trials, including involvement in global study setup.
• Vendor Management : strong, independent vendor management capabilities, with the ability to oversee and coordinate external partners effectively.
• Cohort Management : solid experience in cohort management, with the ability to manage multiple cohorts in a complex study environment.
• Must have strong knowledge of ICH / GCP guidelines and regulatory requirements.
• Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Requires project management skills and trial leadership ability.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Proficient in English.
• Moderate (~25%) travel required.

Preferred Experience

• Ability to thrive in a collaborative, cross-functional environment — working effectively with a range of teams, roles, and personalities.
• Comfortable to also work independently, showing initiative and resourcefulness to problem-solve and exchange ideas with colleagues.
• Flexibility and the ability to manage multiple priorities & working in a global environment.

Education

• A BA / BS degree with proven clinical trial experience, OR an advanced degree (MS / PhD / PharmD) with relevant hands‑on clinical trial experience.

Additional Information

• This is a permanent, full‑time position, based in the United Kingdom.
• This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in office. Flexibility may be required in line with business need.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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