£38,000 ASSOCIATE CLINICAL COMPLIANCE MANAGER

CLINICAL COMPLIANCE MANAGER

Package: £38,000
Duration: Full time
Location: London Bridge

As the UK’s largest early Phase Contract Research Organisation (CRO) uniquely based in central London with excellent transportation links, we invite you to be part of a motivated team with like-minded, proficient, dynamic, and innovative individuals in the role of Clinical Compliance Manager (CCM).

Key duties and responsibilities:
• To check the quality of clinical procedures performed and study data collected, whether it is complete, correct and conforms to the requirements ICH GCP Guidelines and applicable regulations, whether it meets the study criteria defined within the study protocols, study operations manuals and Richmond's standard operating procedures (SOPs)
• To ensure clinical compliance with ICH GCP and all applicable regulations
• To maintain personal training records to the highest standards, ensuring that all Quality Control (QC) examinations are current and that the reading of all SOP’s/SOM’s/CSP’s is up to date
• To perform on the spot QC of data collected in line with daily procedures prior to the end of each shift
• Assist Research Physician to ensure reject files are ready for sign off in timely manner
• To ensure sponsor led monitoring visits lead to neutral (as a minimum) or positive feedback in relation to the clinical quality and turnaround of monitoring queries

Additional responsibilities:
• To supervise and provide QC training to the clinical team members
• To assist the study management team in compiling Clinical Monitoring Plan
• To assist the study management team in compiling and returning the monitoring responses to external monitors within agreed date
• Liaising with Medical Administrator to ensure Research Physician query resolutions are done in timely manner
• Liaising with Data Management team to resolve eCRF/Data Base queries

Key requirements:
• BSc or above in Life Science or Nursing or Pharmacist (not necessarily registered in the UK)
• Minimum 2 years experience in either Clinic or monitoring of clinical data
• Good knowledge of ICH GCP guidelines
• Good knowledge of MHRA early phase accreditations

Applicants must be fluent in English both oral and written; we also welcome applicants who are fluent in Japanese. Attention to detail, self-motivation, enthusiasm and the ability to work well in a team as well as individual are essential.
In return we offer excellent opportunities for training, a generous remuneration package and a generous holiday allowance.
Please provide both CV and a covering letter, the covering letter should include your availability, suitability for the post, interest in the role and eligibility to work in the UK.

Only candidates short-listed will be contacted.