International Clinical Trial Liaison (CTL) - (Oncology / Rare Disease) France
- Employer
- Amplity Health
- Location
- France (FR)
- Salary
- Competitive plus benefits
- Start date
- 4 May 2022
- Closing date
- 3 Jun 2022
View more
- Discipline
- Medical Affairs, Medical Science Liaison, Project Management, Clinical Project Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Clinical Trial Liaison (CTL)
Oncology (Rare Disease)
France
Business Unit: Clinical Development & Regulatory Affairs – outsourced through Amplity Health
Reports to: Amplity Health and Client Clinical Research and Operations Director
Location: France
Territory: France, Belgium, Netherlands & UK
Individual or Manager: Individual
Purpose of Role
The Clinical Trial Liaison (CTL) supports the clinical study execution as the local field-based representative for the sponsor company in one or more countries/regions supporting clinical development programs. The CTL interacts with investigator sites and other parties related to clinical trial execution. The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In collaboration with the study team, the CTL both identifies and helps facilitate resolution of investigator site issues.
JOB REQUIREMENTS
- Engage clinical trial sites to evaluate and develop opportunities to optimize participation and enrolment in sponsor clinical trials
- Maintain command of latest scientific data relevant to the role, knowledge of assigned study protocols related compliance and policy and procedure information
- In close collaboration with the sponsor, engage Key Medical Experts in the therapeutic area as needed to fulfil objectives of the development program
- Act as a scientific resource for clinical trial sites and external experts within assigned therapeutic area and geography
- Refer unsolicited medical inquiries to the study-assigned medical monitor
- Collaborate with Clinical Operations colleagues, including reporting of designated or discovered information important to trial execution
- Support the CRO in the management of issues related to suspected serious non-compliance or any other operational issue that may impact patient safety or data integrity
- Ensure sponsor policies, principles, and financial controls of CTLs activities are maintained with integrity and professionalism
- Frequent travel (including occasional weekends) with overnight trips as necessary to accomplish above objectives
During the study start-up phase
- Attend site initiation visits
- Provide disease area/product background training for site staff
- Answer questions on protocol/study design & feedback to sponsor team
- Identify suitable replacement or rescue sites
During the study maintenance phase
- For site staff turnover: provide disease area/product background/protocol training for site staff
- Provide protocol amendment training to site staff
- Develop an understanding of treatment pathways and local standard of care, to inform recruitment strategies and to feed back to sponsor Clinical team Support development of site-specific enrolment strategies and tactics (incl. advertisement)
- Support development of site-specific retention strategies and tactics
- Support the organization of and attend investigator meetings
- Support CRAs in resolution of site-specific monitoring issues
- Plan and Perform booster/co-monitoring visits (eg in case of protocol amendments, enrolment challenges)
- Support CRO’s staff in the resolution of critical site-specific vendor-related issues (for example, imaging, labs, ECG, CRF Health, pharmacy), if needed
Data quality / database lock / close out phase
- Ensure site is meeting agreed upon benchmarks for data entry, image submission
- Contribute to alleviate specific CRA roadblocks for timely database lock (unresolved queries, missing data, missing images, PI sign off), if needed
Other
- Maintain site contact records (contact template), follow up open issues with sites in writing in close collaboration with the study teams
- Communication/escalation of issues related to study conduct and quality of CRO and/or sponsor team and propose contingency plans to CRA to resolve
- Ensure requests for medical advice for individual patients are correctly managed and/or referred to the study-assigned Medical Monitor for resolution
- Attend regularly scheduled CTL meetings and relevant study team meetings as assigned by line manager
- Support site audit/inspection activities as requested by sponsor compliance/auditing groups
- Support serious suspected non-compliance remediation activities per sponsor process
- Coordinate regular sponsor/investigator interactions and ad hoc ones at conferences
- As requested by sponsor: support external expert identification and coordinate due diligence paper work for advisor contracts
- As requested by sponsor: support external expert relationship development
SCOPE:
- Additional countries may be assigned on an as needed basis
Education
- Masters in life science subject required
- MD, PhD or Pharm D strongly preferred
Experience
- Required: at least 6 years of clinical research experience (either as site investigator, at a CRO or at a sponsor company)
- Strongly preferred: at least 3 years of clinical research experience at a sponsor company
- Track record in designing and/or implementing successful patient recruitment or retention strategies
- Strongly preferred: excellent understanding of local medical practice for management of clinical trial therapeutic area
- Self-starter, ability to work independently, ability to work effectively in remote teams
- Excellent written and oral communication skills
- Required: fluent in local language and in English
About Amplity
Amplity Health is the true partner of global healthcare companies who builds transformational solutions by challenging the boundaries of commercialization strategies to improve the lives of patients.
We do this through:
- Commercialization – Amplity Health has the expertise, people and infrastructure to meet a wide range of commercialization challenges
- Clinical & Medical Outsourced Solutions – Building end to end external engagement solutions and capabilities across clinical and medical affairs globally
- Consulting – Building end to end external engagement solutions and capabilities across clinical and medical affairs globally
- Remote Engagement – Alternative channels across the medical and commercial continuum to engage with HCPs and patients
- Field Outsourced Solutions – Tailored field team programs to meet a wide range of objectives and client needs
Values
These are our company values that we expect all candidates and potential employees to embody as these values strongly underpin our culture:
- Excellence
- Passion
- Integrity
- Innovation
- Collaboration
Amplity Health is an equal opportunities employer. Amplity Health believes that drawing upon the talents of people from diverse backgrounds and experiences enriches our performance. We seek to create an inclusive, fair, and respectful environment that celebrates individual differences and the unique perspectives they bring. Diversity at Amplity Health includes ethnicity, gender, age, religion, disability, national origin, and sexual orientation. It also encompasses recognizing the uniqueness of everyone’s characteristics, styles, and experiences. At Amplity Health, we believe our people are the foundation of our success.
Please note: If you have not received a response to your application within 4 weeks, you have not been successful on this occasion. Please register on our portal for other opportunities
Company
Amplity Health is a contract medical and commercial organization that is the True Partner of Global Healthcare Companies. We continually challenges the boundaries of medical and commercial strategies to accelerate the approval and launch of new drugs to improve the lives of patients. With experts on six continents in over 30 countries, Amplity has the expertise, global infrastructure, and data-driven insights to help clients overcome their medical and commercial challenges.
We are proud of our inclusive culture and our EPIIC values, which are reinforced in our people, our processes, and the solutions we provide for our clients:
Hear more about our EPIIC values from our Chief of Staff:
Hear from our VP, Medical Solutions about why you might want to consider a career with us:
- Website
- https://www.amplity.com/
- Telephone
- 01753251321
- Location
-
Amplity House
The Vale
Chalfont St Peter
Buckinghamshire
SL9 9RZ
United Kingdom
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