The role coordinates all aspects of local study management. Responsible for the local implementation of international clinical trials/local trials entrusted to them, their preparation for their closure, in compliance with GCP, regulatory requirements, SOPs, quality standards, deadlines and costs.
Oversight of the Clinical Research Associates who are allocated to a project on a Country basis. You will work in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in position for the clinical team & be primarily responsible for the clinical deliverables within agreed timelines and budget of the Project. Clinical Team Managers provide contact and support to the project sponsor for all clinical activities.
We are seeking individuals who are high performing & enjoy a fast-paced environment with Clinical Management experience OR exposure to international/local studies, involving the coordination of CRAs locally and potentially across different countries. With your excellent written and oral English and German skills you will have exceptional interpersonal and problem-solving skills, with the ability to lead CRAs. You will also have proficient working knowledge of GCP and experience in several therapeutic areas. You must be comfortable working in a matrix management system and have the ability to motivate, mentor and integrate teams.
Education and Experience:
- Bachelor's degree or licenced certified health care training or equivalent combination of education and experience.
- Clinical research experience in all phases of study life cycle, including start up, interim and close out.
- Equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Valid Driver's Licence.
- Valid Passport.
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.
- knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc