TMF Lead

Trial Master File Lead

As a global provider of drug development solutions, our work is serious business. That doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for a passionate, resilient, and inspiring individual to join our team as TMF lead. Based in the US, we offer flexible working as either a Homeworker or an Office Based employee;

The role:

• Proactively manages the system and people to ensure study TMFs are Inspection Ready.

• Monitors the health of the TMF and provides actionable analysis to improve completeness, quality and timeliness.

• Serves as the eTMF Subject Matter Expert and primary Point of Contact for ICON and Sponsor study team members, listening to and collaborating with them to drive TMF success.

• Actively identifies continuous improvement opportunities and enhances operational efficiency.

Requirements:

• Bachelor's Degree

• Minimum of 3 years TMF experience with at least 1 year of Veeva Vault eTMF experience

• Knowledge of ALCOA+, Good Clinical Practice, Good Documentation Practice, International Council for Harmonization guidelines, and TMF Reference Model

• Excellent organizational and negotiation skills, the ability to manage multiple tasks and exceptional attention to detail

• Strong written and verbal communication skills to effectively work with global teams

• Proficiency in Microsoft Outlook, PowerPoint and Excel

Why join us?

• Ongoing development is vital to us, and as a TMF Lead you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.