Senior Clinical Trial Manager - Oncology (Europe)

Worldwide Clinical Trials; Deutschland; Remote; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials is seeking an experienced Senior CTM/CRA for our Clinical Operations team in Germany. You will lead site management from initiation to closeout, coordinate CTM activities regionally, and act as primary contact for sponsor and investigator meetings. You will help shape global monitoring plans and support audits and inspections.

We value oncology experience, strong leadership, and the ability to manage a remote team. Travel flexibility is required as part of the role.

Qualifikationen

• Minimum degree in biological, physical or health studies with 4 years CRA experience.
• Alternate: 2-year degree plus 6+ years as Senior CRA/CTM.
• Minimum 2 years as CTM/LCRA overseeing a CTM team.
• Experience in Oncology studies is required.

Aufgaben

• Provide leadership to clinical site management from start to close.
• Oversee regional CTMs and coordinate CTM team efforts.
• Represent site management in sponsor and investigator meetings.
• Develop global monitoring strategies for initiation, enrolment and closeout.
• Mentor CTMs and perform co-monitoring visits as needed.
• Review trip reports and support inspections by authorities.

Kenntnisse

Interpersonal communication

Remote team leadership

Problem solving

Customer focus

MS Office / CTMS / EDC

Ausbildung

Biological/physical/health studies (4-year college)

Nursing or life science (2-year)

Tools

CTMS

EDC Systems

Microsoft Office

Jobbeschreibung

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.Join us!

What the Clinical Operations Department does at Worldwide

Embark on a fulfilling Clinical Operations career as you leave a lasting impact on patients’ lives. Join Worldwide Clinical Trials for an unparalleled CRO experience, where you can drive extraordinary scientific breakthroughs and contribute to the very heart of every successful clinical trial.

Working alongside brilliant minds across a variety of therapeutic areas, you will have the chance to collaborate closely with top-tier colleagues from diverse backgrounds and specialties. Our commitment to advancing clinical research is cultivated in a supportive, team-oriented atmosphere, with our hands-on leadership and dedicated team members working together to innovate and solve complex challenges for our customers.

What you will do

• Provide leadership and direction to clinical site management team members from study start through closure.
• Oversee regional CTMs and coordinates efforts across the CTM team.
• Represent Site Management issues at Sponsor, Investigator and Bid defense meetings and act as main point of contact for activities through the study.
• Contributes to the overall project plan, by formulating a global monitoring strategy for site initiation, enrolment, site management and closeout phases across a given region and assigns sites on behalf of the sponsor.
• When needed, assumes dual PM/CTM role.
• Develop, maintain and ensure compliance with Clinical Monitoring Plans, including budgets, study tools and Site visit reports; perform regular review of protocol deviations, Out of Scope items and oversight of action items.
• Training and management of CRA team on all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed.
• Participate in the development of and implementation of recruitment strategy in countries and sites assigned.
• Accountable for Forecasting of site visits w/CRA team to ensure staffing needs are met and any identified backlog is appropriately addressed
• May act as a mentor for CTMs.
• Performs Co-monitoring visits where required.
• If needed, Review/finalize trip reports according to WCT SOPs, expectations and as outlined in the annotated report.
• Supports the study team during inspections by healthcare authorities or sponsor audits.

What you will bring to the role

• Excellent interpersonal, oral, and written communication skills in English and in local language.
• Ability to lead and motivate a team remotely.
• Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified.
• Strong customer focus, ability to interact professionally within a sponsor contact.
• Proficiency in Microsoft Office, CTMS, and EDC Systems.

Your experience

• 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 6years 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.
• Willingness to travel.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide!For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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’reon a mission to hire thevery bestand 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 .