Senior Clinical Trial Manager - Oncology (Europe)

WCT Worldwide Clinical Trials GER GmbH

Polska

Híbrido

PLN 306.000 - 481.000

Jornada completa

Hace 8 días

Una candidatura completa en un minuto

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Descripción de la vacante

Worldwide Clinical Trials seeks a Senior Clinical Trial Manager to lead site management across studies and regions, ensuring quality, efficiency and regulatory compliance.

You will collaborate with project management, sponsors, CRAs, and cross-functional teams to drive performance, monitor strategies, and support from qualification to closeout. This is a remote Europe-based role with travel as needed.

Formación

  • Four-year degree in biological, physical, or health studies with 4+ years as a Senior CRA.
  • Two-year degree (nursing or life science) with 6+ years as a Senior CRA and 2+ years as CTM/LCRA.
  • Oncology experience is required.
  • Strong regulatory knowledge (FDA/EU, ICH, SOPs).
  • Proficiency with MS Office and clinical systems (EDC, CTMS, IxRS/IVRS, eCRF).

Responsabilidades

  • Lead and coordinate clinical site management from study startup to closeout.
  • Develop monitoring strategies with project management.
  • Provide leadership to CRAs and site management teams.
  • Serve as primary site management representative for sponsors and audits.
  • Drive quality and compliance with monitoring activities and inspection readiness.
  • Monitor study metrics, recruitment, resources, and risks.
  • Support patient recruitment and site-specific strategies.
  • Ensure Trial Master File compliance and timely documentation.
  • Identify and mitigate risks while supporting continuous improvement.

Conocimientos

Clinical trial management
Leadership of remote teams
Site management and monitoring
Regulatory compliance (FDA/ICH/EU)
CTMS / EDC familiarity

Educación

Bachelor's degree in life sciences
Four-year degree in biological/health sciences

Herramientas

EDC platforms
CTMS
IxRS/IVRS
eCRF platforms

Descripción del empleo

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs– in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Make an Impact as a Senior Clinical Trial Manager at Worldwide

As a Senior Clinical Trial Manager, you will lead the delivery of critical clinical site management activities across studies and regions, helping ensure research is conducted with quality, efficiency, and compliance at every stage. Your leadership will directly support the successful execution of clinical trials and contribute to bringing new therapies to patients. In this role, you will partner closely with project management, sponsors, CRAs, and cross‑functional teams to drive study performance, oversee monitoring strategies, and ensure sites are supported from qualification through closeout. You'll play a pivotal role in risk management, team leadership, operational excellence, and the delivery of high‑quality clinical outcomes. You will also serve as a key point of contact for sponsors and study teams, providing strategic oversight, mentoring site management teams, and ensuring clinical operations remain aligned with study goals, timelines, and quality expectations.

Where You’ll Work

This is a remote role open to candidates based in Europe. You will collaborate with global teams across multiple time zones. Travel will be required on an as‑needed basis.

What You’ll Do
  • Lead and coordinate clinical site management activities from study startup through database lock and study closeout.
  • Partner with project management to develop monitoring strategies, establish site management targets, and ensure delivery against project goals.
  • Provide leadership, guidance, and oversight to CRAs and site management team members across assigned studies and regions.
  • Serve as the primary site management representative for sponsors, study teams, investigator meetings, audits, inspections, and key project discussions.
  • Drive quality and compliance by overseeing monitoring activities, reviewing protocol deviations, ensuring adherence to Clinical Monitoring Plans, and maintaining inspection readiness.
  • Monitor study metrics, recruitment performance, resource allocation, and operational trends to identify risks and implement effective solutions.
  • Support patient recruitment efforts by tracking enrollment progress and guiding site‑specific recruitment strategies to maintain study targets.
  • Ensure Trial Master File compliance and oversee the timely completion and quality review of site‑management documentation.
  • Proactively identify, escalade, and mitigate operational and monitoring risks while supporting issue resolution and continuous improvement initiatives.
What You’ll Bring
  • Four‑year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of 4 years as a Senior Clinical Research Associate (or equivalent), OR Two‑year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of 6 years as a Senior Clinical Research Associate, AND Minimum 2 years relevant experience as a CTM/LCRA (or equivalent) including overseeing a CTM team.
  • Experience working with Oncology studies is required for this role.
  • Experience leading or coordinating clinical monitoring and site management activities within clinical trials.
  • Strong understanding of clinical research principles, site management processes, and monitoring best practices.
  • Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and clinical trial SOPs.
  • Experience reviewing study metrics, managing operational risks, supporting recruitment activities, and maintaining high‑quality study documentation.
  • Proficiency with Microsoft Office and clinical systems including EDC, CTMS, IxRS/IVRS, and eCRF platforms.
  • Demonstrated ability to lead and motivate remote teams, influence stakeholders, solve complex problems, and manage multiple priorities effectively.
  • Proficiency in English, with excellent written, verbal, presentation, and interpersonal communication skills.

We love knowing that someone is going to have a better life because of the work we do. Discover a world of difference at Worldwide!

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.

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