Associate Director - Trial Master File Operations

April 15

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Praxis

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Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

Patient Profiling • Analyzing Market Potential • Media Strategy • Creative Design & Development • Media Placement

11 - 50 employees

Founded 2002

🧬 Biotechnology

⚕️ Healthcare Insurance

🔬 Science

📋 Description

• This position is responsible for leading the TMF (Trial Master File) operations function for clinical trials across Praxis. • To excel in this position, you are a strategic and collaborative leader capable of critically assessing and improving processes to meet rigorous quality standards. • Ultimately, you are responsible for the completeness, accuracy, and regulatory compliance of TMFs. • As part of this responsibility, you oversee all TMF-related activities across all of Praxis’ clinical trials.

🎯 Requirements

• Minimum of 8+ years of related experience with a Bachelor's degree • Deep understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations • Extensive experience with electronic Trial Master File systems (Veeva strongly preferred) and related technology platforms • Sound knowledge of DIA TMF Reference Model • Effective knowledge of clinical trial operations and processes, preferred • Demonstrated leadership skills to drive results • Excellent communication skills and ability to collaborate with cross-functional teams to achieve results • Ability to effectively manage priorities simultaneously and overdeliver • Ability to travel as needed to meet business needs

🏖️ Benefits

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans • Bonus program structured to pay on a quarterly basis • 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth) • Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more • Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit • Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)