Overview
Parexel is currently seeking a Senior Clinical Study Administrator (Sr CSA) to join us in a hybrid remote/office-based role in Luton, UK. The role operates from the sponsor site in the Luton area for up to 3 days/week.
Working as a Sr CSA at Parexel FSP offers tremendous prospects. We undertake vital clinical studies for sponsors including leading global biotechs and Pharma top 50, and we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, with time for your outside life.
Responsibilities
* Assists in coordination and administration of clinical studies from the start-up to execution and closeout. Serves as local administrative main contact and works closely with CRAs and/or trial managers for the duration of the study.
* Sets up, populates and accurately maintains information in client tracking tools and communication systems (e.g., CTMS such as VCV, SharePoint) and supports others in the usage of these systems.
* Manages and contributes to coordination and tracking of study materials and equipment.
* Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
* Leads practical arrangements and contributes to the preparation of internal and external meetings. Liaises with internal/external participants and vendors in line with international and local codes.
* Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.
Document Management
* Interfaces with Investigators, external service providers and CRAs during document collection to support effective delivery of a study and its documents.
* Maintains the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) including document tracking in accordance with ICH-GCP and local requirements.
* Ensures essential documents are uploaded in a timely manner to maintain the eTMF. Supports CRA close-out activities for ISF.
* Responsible for layout, language control, copying and distribution of documents. Supports local translation and spell checks in English to/from local language as required.
Regulatory and Site Start Up
* Collects, assists in preparation, reviews, and tracks documents for the application process.
* Assists in timely submission of application documents to EC/IRB and, where appropriate, to Regulatory Authorities for the duration of the study.
* Creates/imports clinical-regulatory documents into the Global Electronic Management System (e.g., ANGEL) ensuring compliance with the Client Authoring Guide for Regulatory Documents.
* Contributes to electronic submissions by handling clinical regulatory documents according to Submission Ready Standards (SRS), supporting publishing and delivery to regulatory authorities.
Budgeting, Agreements and Payments
* Prepares and/or supports contract preparation at a site level.
* Prepares/supports Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
Qualifications
* High school/Secondary school qualifications (or equivalent) that support skills and capabilities of the position and interactions with internal and/or external customers.
* Proven organizational and administrative skills.
* IT proficiency.
* Fluent in written and spoken English.
* Previous administrative experience preferably in the medical/life science field.
* Understanding of the Clinical Study Process and ICH-GCP guidelines is preferred.
* Good verbal and written communication; strong interpersonal skills; ability to work in an international team environment.
* Willingness and ability to train others on study administration procedures.
* Excellent organization and time management skills with attention to detail.
* Ability to multi-task in a high-volume environment with shifting priorities.
* Team-oriented and flexible; able to respond quickly to shifting demands and opportunities.
* Integrity and high ethical standards.
We care about our people and our passion, as they are key to our success, and provide an open and friendly work environment where we empower people and provide opportunities to develop long-term careers. You will have the opportunity to develop within your role and tackle further responsibilities or develop skills within other related Parexel departments.
About Parexel
Parexel supports clinical studies across the full range of therapeutic areas, with longstanding partnerships across a vast client base. We have supported trials of many top-selling drugs and enable niche drug developments that are critical to patient well-being. You’ll be an influential member of the wider team.
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