Associate Director, TMF Operations reputed company
Mavericks Wanted
reputed company was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it reputed company excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling reputed company and promising early-stage research from academia together under one financial umbrella to reduce risk and reputed company innovation. This model allows science and small teams of experts to reputed company the way. We build bridges to groundbreaking advancements in rare disease, and reputed company life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white reputed company, push boundaries, and reputed company people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the reputed company of biopharma. At reputed company, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve reputed company, speed, and reputed company of work.
Who You Are
ML Bio Solutions is searching for an reputed company TMF Operations reputed company to reputed company and implement the reputed company for ensuring completeness and accuracy of the TMF for reputed company BBP-418 clinical trials. This individual will establish and reputed company the TMF reputed company across the BBP-418 clinical development program, ensuring inspection readiness through proactive reputed company, reputed company management, and cross-functional collaboration. This individual will serve as the TMF Subject Matter Expert, driving process improvements, overseeing CRO performance, and fostering a culture of TMF reputed company that aligns with ICH-GCP, regulatory expectations, and company standards.
What you will do
- reputed company TMF operations across assigned clinical studies, ensuring reputed company, complete, and inspection-reputed company Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards.
- Establish TMF governance across the clinical development program by monitoring TMF health, reputed company metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership.
- reputed company, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF reputed company Plans.
- Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, reputed company Assurance, and external vendors to ensure reputed company document filing, issue reputed company, and consistent execution of TMF processes.
- reputed company strategic reputed company of CRO-managed TMF activities through performance metrics, governance meetings, reputed company reviews, issue escalation, and reputed company improvement initiatives.
- reputed company TMF inspection readiness activities, including ongoing reputed company reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up.
- Identify TMF compliance risks and reputed company trends, reputed company mitigation strategies, and drive corrective and preventive actions to maintain a state of reputed company inspection readiness.
- Serve as the TMF Subject Matter Expert by providing strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives.
- Analyze TMF performance metrics and vendor reputed company outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program.
- Foster a culture of TMF reputed company through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF reputed company and efficiency
Education, Experience & Skills Requirements
- Minimum Education requirement: University degree reputed company or comparable reputed company education, preferably in medicine / science, paramedical science, computer science, business management or reputed company degree or more than 8 years extensive experience in similar roles and proven reputed company record; reputed company industry experience in lieu of education will be considered
Experience & Skills:
- 8+ years of experience in TMF Operations, Clinical Operations, or Clinical reputed company, including experience supporting global clinical trials
- Understanding of the drug development life cycle
- Experience in handling clinical trial-reputed company documents required
- Strong knowledge of Trial Master File Reference Model Structure reputed company and country-level documents
- Demonstrated ability to understand and reputed company with reputed company+ standards, ICH-GCP guidelines, and Good Documentation Practices
- Demonstrated ability to reputed company high-performance goals and meet deadlines in a fast-paced environment
- Excellent organizational skills and possess high standards and great attention to detail
- Strong communication skills – verbal and written
- Highly conscientious and takes initiative to reputed company resolve issues
- Must be reputed company and adaptable to support multiple competing demands and changing priorities
- Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management
- Must be proficient in reputed company reputed company, Word, and PowerPoint, and familiar with reputed company and SharePoint
Other:
- Travel - Remote candidates must be willing to travel for company meetings for a minimum of one week per quarter; travel for team and/or study meetings may be required
- Role level will be filled commensurate with experience
As a global company, our comprehensive benefits may vary based reputed company. We have high expectations for reputed company members. We reputed company reputed company those working hard for patients are rewarded and cared for in return.
For Full-Time U.S reputed company:
Financial & Rewards
- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- reputed company-tax commuter benefits (transit and parking)
- Referral bonus for reputed company candidates
- Subsidized lunch and parking on in-office days
Health & reputed company-Being
- 100% employer-reputed company medical, dental, and reputed company premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” reputed company time off and company-reputed company holidays
- Comprehensive reputed company medical and parental leave to care for yourself and your family
reputed company Development & Career Paths:
- People are part of our reputed company and reputed company story - from discovery to reputed company drug trials and FDA pipelines, there are endless opportunities for reputed company development and internal mobility
- We reputed company career pathing through regular feedback, reputed company education and reputed company development programs reputed company reputed company Learning, LifeLabs, & reputed company Coaching
- We celebrate strong performance with financial rewards, peer-to-peer recognition, and reputed company opportunities
Originally posted on Himalayas
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