Clinical Trial Specialist / Associate Clinical Trial Manager - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel are currently recruiting for an experienced Global Clinical Trial Coordinator, to join one of our fastest growing oncology sponsors in Europe as a Clinical Trial Specialist. In this role you will be accountable for supporting moderately complex clinical study activities in support of the Clinical Trial Manager. You will work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOPs. You may assist with vendor oversight and management with guidance, by helping to identify issues in a timely manner and escalate to management as appropriate. You may complete monitoring visit report review and perform co-monitoring or monitoring oversight visits. This will be a fully remote home-based position.

Some specifics about this advertised role:

• Support Phase 1, 2, 3 and 4 clinical studies with guidance.
• 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 (including but not limited to Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.).
• Study Trial Master File (TMF) oversight.
• Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations.
• Organize study related meetings including but not limited to preparation of agenda/minute taking and maintenance of risk/issue/decision logs.
• May lead and present at study related meetings.
• May perform applicable site monitoring/co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits).

Who are Parexel:

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients. You’ll be an influential member of the wider team.

What we are looking for in this role:

• M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential.
• At least 3 years of experience (4yrs 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.

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