Job Description

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 a Senior Clinical Assistant to join us in either the UK, Ireland, Spain or Poland dedicated to a single sponsor and focused on non-interventional studies. (This will be a fully remote position).

The Senior Clinical Assistant will support Clinical/Brand Team on various operational aspects of assigned projects/activities: clinical studies (mainly non-interventional, from early phase to late phase) and/or other clinical services (e.g. managed access programs (MAP), Research Collaborations, IIT, Digital Solutions etc.) or specific standalone services.

Working as a Senior Clinical Assistant at Parexel FSP offers tremendous 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

• Execute clinical services and meet planned deliverables in line with defined roles and responsibilities agreed with colleagues/customers.

• Support set-up and maintenance of information in Clinical Trial Management Systems (CTMS) and other systems as applicable: Update data, timelines, milestones, EC/HA authorizations, etc. on an ongoing basis.

• Support Clinical Project Manager (CPM) with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.

• Support set-up and maintenance of Trial Master File (TMF): Ensuring that all key documents are present and filed as appropriate in TMF, under responsibility of COS or CPM as applicable. Follow up with Clinical Trial Team (CTT) at agreed frequency for TMF maintenance.

• Track clinical service progress, ensure CTMS, TMF and other systems as applicable are up to date, report to colleague/customer as per scope of work. Address questions; escalate issues or critical findings to project lead (CPM).

• Support CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for study start during study conduct and close-out. Follow-up with External Service Providers on day-to-day operations.

• Ensure all data is reported to the Clinical Trial Team and available to colleagues/customer.

• Logistical support to study team (internal and external) onboarding process.

• Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.

• Support CTT in study start-up activities, recruitment and close-out activities as required.

• Champion the implementation of operational changes and transitions as required.

• As applicable, support CPM in directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and conduct, reviewing site performance (e.g. queries, recruitment), protocol deviations, ongoing risk assessment and timely issue resolution in alignment with global standard and local regulatory requirement.

• If needed, support clinical studies with all onsite/remote monitoring activities and communications with investigators, investigational sites, clinical trial team, healthcare professional and other associated internal line-functions.

Here are a few requirements specific to this advertised role.

Education:

• Relevant educational background in life sciences/healthcare (Ideally a bachelor’s degree or above in life sciences) or equivalent combination of education, training and experience.

Skills & Experience:

• Approximately 3-4 years of operational experience of clinical study execution in a pharmaceutical company or contract research organization.

• Experience in finance: forecast, actuals, cost reconciliation, a plus.

• Strong technical and organizational skills (Excel, MP,), Details oriented.

• Thorough knowledge of Good Clinical practice.

• Demonstrated ability to establish effective working relationships in a matrix and multicultural environment.

• Demonstrated presentation and diplomacy skills.

• Strong customer-oriented mindset.

• Willingness to act accountably in project/study management.

• Proficient in written and spoken English.

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

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.

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