Senior Clinical Trial Associate

• Job Title: Senior Clinical Trial Associate (CTA)
• Company: Global Biopharma (FSP)
• Contract: Full Time, Permanent
• Location: Hybrid with 1-2 days per week in the office (Flemish Region)

RBW Consulting is thrilled to present an exciting opportunity to join a leading global biopharma company through an outsourced model with a CRO. Earlier this year, we successfully placed a Senior CTA within this framework, who shared glowing feedback about their experience. They praised the positive relationship between the CRO and the biopharma, highlighting the latter's commitment to quality over quantity.

The biopharma is known for its open-door policy and streamlined structure, which fosters direct communication between employees and senior leadership. Our placed CTA described the biopharma as a wonderful place to work, with promising career prospects and greater flexibility compared to their previous employer. They also appreciated the opportunity to participate in face-to-face investigator meetings, feeling more involved and valued. Additionally, the biopharma encourages ownership and autonomy in process improvements, ensuring that employees' voices are heard and prioritized.

Responsibilities

• Support the CRAs and CPMs
• Ensure that the trial is documented in compliance with GCP and all applicable regulatory requirements.
• Work according to the applicable quality management system of the client.
• Tasks
• Support the CRA(s) and CPM(s) with all aspects of administration to ensure smooth conduct of the trial.
• Set up the Trial Master File (TMF) and Investigator Site File (ISF).
• Assist with the preparation and collection of essential clinical trial documents.
• Act as TMF owner and maintain all required essential documents in the TMF, including periodic review of files for completeness, preparation for internal/external audits, final reconciliation, and archival.
• Coordinate ordering and tracking of trial materials and shipment of supplies to sites and monitor study supply levels.
• Coordinate document translation.
• Track, process, and release payments to sites in collaboration with the trial team and finance department.
• Attend project team meetings and generate meeting minutes.
• Perform submissions to Ethical Committees and Regulatory Authorities: initial submissions, notifications, amendments, and safety information, among others.
• Assist the CRA(s) in preparing, conducting, and reporting site selection, initiation, monitoring, and close-out visits.
• Work proactively to avoid problems from occurring.

Job Criteria

• Life science degree or equivalent
• Preferably at least 3 years of experience in (international) clinical research.
• Fluent English speaking
• Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint), internet; experience with eTMF (e.g., Veeva Vault); any experience with CTMS, eCRF systems is an advantage.

To apply

Please click ‘apply’ or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.