CRA Manager

SUPERVISION

• * Ensure CRAs perform monitoring and site management responsibilities to an appropriate working standard including (but not limited to):
- updating study files
- completing trip reports and follow-up letters in a timely manner
- managing investigational product
- completing source data verification
- developing effective relationships with sites
• * Monitor and evaluate CRA workload and liaise with Resource Management, the relevant Project Manager and Director of Clinical Operations (as needed), to ensure appropriate allocation of resources and optimal utilization and workload.
• * Identify and ensure all necessary training is provided to CRAs on an ongoing basis to optimise job performance and knowledge with particular emphasis on all relevant ICON procedures, ICH-GCP and other local regulations.
• * Accompany CRAs to provide on-site training for pre-study, initiation, monitoring and close-out visits. These visits should be conducted until the CRA has demonstrated the ability to conduct visits unassisted. Maintain a record of all accompanied visits, including those performed by others.
• * Conduct on-site Monitor Assessment Visits as required.
• * Implement individual development plans and provide coaching and mentoring to assigned CRAs.
• * Maintain regular 1:1 communication with all assigned CRAs.
• * Approve vacation time and leave requests (consulting Project Managers as appropriate).

QUALIFICATIONS/EXPERIENCE REQUIRED:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Experience:
• US/LATAM/CAN: a minimum of six (6) years of clinical research experience, with at least four (4) years of relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least two (2) years as a Project Manager, CRA Manager or equivalent job role.
• EU/APAC: in depth proven experience as a Senior CRA or Principal CRA (in a Lead CRA role), Project Manager, CRA Manager or equivalent job role.
• Prior experience of managing CRAs.
• Fundamental knowledge of Clinical Research, and expertise in all phases of a clinical trial.
• Good experience of in field clinical monitoring.
• Comprehensive knowledge and understanding of ICH-GCP.
• Previous experience in delivering training.
• Ability to liaise successfully with clinical project teams and other relevant departments.
• Demonstrated ability to identify, analyze and solve problems.
• Excellent interpersonal and communication skills.
• Excellent organization and time management skills.
• Excellent computer skills.
• Excellent written and spoken English.
• Good cross cultural sensitivity.
• Due to nature of this position, the employee will be required to travel. Therefore, dependent on the employee’s location, a valid driver’s license will be required.
• This position will be office or home based depending on the regional structure.

EDUCATION REQUIREMENTS

Bachelors Degree, or local equivalent, in life sciences, medicine or related discipline.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
What’s Next
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.