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 is currently seeking Clinical Study Team Associates with European or global experience, based in the UK.
The Clinical Study Team Associate (CSTA) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for multiple tasks that span from study start up to study close out which enables the efficient execution of clinical trials to high quality standards.
Key Accountabilities
Responsible for providing study level operational support to the study team from study start up to close out and submission. Tracks and oversees study information; follows up with functional lines as needed.
Maintenance and oversight of study team shared spaces. Maintains and oversees Study Team on Demand (STOD).
Trial Master File (TMF) maintenance, compliance, and oversight.
Maintains client registries and systems as required to ensure compliance.
Liaises with cross functional study team members: Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems.
Provides study level reporting to support management of clinical trial data, clinical trial budget and timelines.
Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission.
Supports engagement of Independent Oversight Committees.
Provides support with audit and inspection readiness activities.
Assists with oversight and tracking of clinical trial budget spend.
Provides logistical and operational support for Investigator Meetings.
Coordinates the translation of documents as required.
Provides status updates on key tasks and contributes to study team meetings.
Provides support to study teams with system setup and maintenance.
Provide support for global study team communications to sites.
Skills and Experience:
Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS).
Effective verbal and written communication skills.
Fluency in written and spoken English required.
Global or pan-European experience in a similar position.
Ability to work independently but also as part of a larger team with limited support from supervisor; ability to multitask and manage multiple competing priorities.
Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality.
Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
Good problem solving and decision-making skills; seeks input from others when faced with a difficult situation; makes sound decisions within the scope of responsibility.
Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.
Education:
Bachelor’s degree with 2 years’ experience, or master’s degree or MBA.
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Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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