Clinical Trial Manager EAMEA (m/v)
The Clinical Trial/Team Manager is a study manager position accountable for achieving the final clinical deliverable within the time period specified in the contract with the Customer. The CTM will be able to interpret data on project issues and make good business decisions with support from experienced team members or line management. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.
Responsibilities may include:
- Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
- Develops Clinical tools, Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
- Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File
- May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
- In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.
- Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies.
- Responsible for the timely archiving of documents and study materials for the clinical department.
- Monitors clinical activity timelines and metrics.
- Provides regular status updates to PM for client reports.
- Ensures regular project review, using the company's tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.
- Reviews monitoring visit reports and ensures finalization is within contractual timeline.
- Manages CRF collection and query resolution process
- Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.
- Leads regular conference call meetings with monitors and other clinical team members.
- May participate in bid defense meetings.
Wat wij van jou vragen:
Education and Experience:
- Bachelor's degree or licensed certified health care training
- Significant clinical research experience (comparable to 3 years) in all phases of study life cycle, including start up, interim and close out
- Previous experience as a field CRA (preferred)
- CRO/Pharma experience (preferred)
- Valid Driver's License and Passport
- Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Superior organizational skills
- Demonstrated performance management abilities
- Extensive monitoring experience
- Excellent judgment and decision making skills
- Effective oral and written communication skills
- Excellent interpersonal skills and problem solving ability
- Ability to motivate and integrate teams and teach/mentor team members
- Able to effectively prioritize workload
- Strong attention to detail
- Expert knowledge of relevant regulations e.g. ICH/Good Clinical Practices, FDA guidelines, etc.
- Computer skills
- Able to communicate in English, both orally and in writing
- Ability to travel
Work is performed in an office/ laboratory and/or a clinical environment. You'll be exposed to biological fluids with potential exposure to infectious organisms. There is exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.
Wat wij jou bieden:
An international challenging environment. A temporary contract with the option of getting a fixed position.
Get in contact by e-mail: firstname.lastname@example.org or by phone on 02 709 07 00 / 0472 18 72 68