Associate Clinical Operations Leader (Clinical Trial Specialist) - UK or South Africa (Home-bas[...]

Parexel is hiring for Associate Clinical Operations Leaders (Clinical Trial Specialists) to join us in the UK or South Africa, dedicated to a single sponsor. These roles will be responsible for supporting the Clinical Trial Manager and the wider clinical trial team to ensure activities are conducted according to Good Clinical Practice (GCP) and relevant SOPs and helping to identify issues in a timely manner and escalate to management as appropriate. It may involve assisting with vendor oversight and management and completing monitoring visit report reviews and occasionally performing co-monitoring or monitoring oversight visits. Working as an Associate Clinical Operations Leader (Clinical Trial Specialist) at Parexel FSP offers long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50, and we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Support activities related to study/site feasibility, start-up, maintenance, and close-out.
• Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out.
• With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable.
• Study Trial Master File oversight, review and filing.
• Organise study related meetings including but not limited to preparation of agenda/minute taking and maintenance of risk/issue/decision logs.
• May perform applicable site monitoring/co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).
• Provides rapid action to address both internal and site QA findings from audits.
• May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation.
• General study tracking and maintenance and study site oversight including but not limited to site performance, metrics, monitoring report review, etc.
• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.
• Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.).
• Review and verification of contracted vendor activities including vendor invoice review.

Qualifications

• Bachelor’s, nursing degree or equivalent required, science preferred.
• At least 2 years of experience (3 yrs preferred) in clinical studies (Pharmaceutical industry experience preferred).
• Previous site monitoring or study coordinator experience is preferred.
• Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures.
• Understanding of study phases and general knowledge of how they apply to clinical development.
• Demonstrated ability to work independently and in a team environment.
• Advanced knowledge of Word, Excel, and PowerPoint.
• Working knowledge of electronic systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.).
• Knowledge of the principles and practices of computer applications in database management.
• Strong verbal and written communication skills required.
• 10% - 20% travel may be required.