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Senior/CRA Manager - Sponsor dedicated
- Clinical Research
- Permanent
- Denmark
This vacancy has now expired. Please see similar roles below...
Proclinical is working with a leading CRO that is seeking a CRA manager to be based in Copenhagen on a permanent basis. This CRA manager will manage the human, material, system and fiscal resources to provide clinical monitoring services within a designated office, country or region. Ensure that clinical staff (CTAs, CRAs and/or CRSs) gains the necessary skills to perform their respective job responsibilities.
Job Responsibilties:
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Participate in the selection and onboarding process for new clinical staff by conducting candidate review and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Learning and Development training programs.
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and mentored training experiences, as applicable.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
- Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
- May fill in as a CRA or CRS for a defined project or to assist with milestone achievement on a temporary basis.
- May participate in clinical operations quality or process initiatives.
Skills and Requirements:
- Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Strong leadership skills
- Fluent Danish and English language skills
- Experience in international Project Management including Finance part
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Strong written and verbal communication skills
- Excellent organizational and problem-solving skills
- Effective time management skills and ability to manage competing priorities
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Bachelor's degree in a health care or other scientific discipline or educational equivalent;
- 7 yrs of clinical trials experience including 3-year experience in a leadership capacity; or equivalent combination of education, training and experience"
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Theodora Savlovschi-Wicks on +44 203 7520 314 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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