Russell Oakley is recruiting for a Global Study Associate to join a Pharmaceutical company based in Hertfordshire on a contract basis for 12 months in the first instance.
The main purpose of the role will be to:
Responsible for providing operational support to multiple study teams through all phases of clinical study management (Plan, Start-up, Conduct, and Close-out) in accordance with appropriate quality standards including ICH/GCP and applicable regulations.
Further responsibilities will include:
Provides operational support to multiple global study management teams (SMTs):
· Develops and maintains effective working relationships with members of the SMT involved in running clinical studies such as GSMs, GSLs, affiliate team members, CRO partners and vendors.
· Assists the GSM with effective communication and information sharing within the SMT and with external partners.
Responsible for reviewing and maintaining accurate study level progress information and the efficient use of systems, tools and reports:
· Contributes to the development, set up and maintenance of study specific tools.
· Reviews standard study related reports and liaises with accountable study members to address any inconsistencies and missing information, as appropriate.
· Ensures any data compliance or quality issues are escalated through the correct pathway.
· Provides the SMT with guidance and know how to support the effective use of system functionality and reports to ensure consistency across SMTs.
Coordinates activities to ensure CRO and vendor delivery against the contracted scope of work:
· Responsible for communication between the study team and vendor for defined tasks and tracking information.
· Trouble shoot issues ensuring vendor and CROs are working according to the contracted Scope of Work. Escalate to the study team as appropriate.
· Ensure essential study information is tracked.
Identifies and contributes to areas of best practice and process improvements:
· Proactively incorporates learning's and recommendations from other study debriefs and best practices.
· Promote standardisation and foster improvements in efficiency in Study Management practices and processes ensuring consistent delivery across studies.
Contributes to functional excellence activities:
· Participates in Product Development Operations initiatives and programmes.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
Bachelor's degree with experience in a clinical research or health care related industry, or equivalent combination of education and experience. Life sciences degree or nursing equivalent is preferred.
• Knowledge of ICH/GCP
• Experience of working as part of large team with a proven ability to make an active contribution to the team's performance and team working.
• Proven effectiveness with written and verbal communication skills.
• Proficient computer skills across multiple applications
• Prioritises and multitasks to ensure that tasks are completed on time
• Self-motivated and displays initiative (resourceful) - for instance to move actions forward without the need for continual supervision.
• Collaboration and Teamwork
• Service/Customer Management
• Personal Organization
• Accuracy and Attention to Detail
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL42026 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 1st May 2018
- Expires: 29th May 2018
- Reference: CL42026