TMF Specialist

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.
About The Role
The Trial Master File (TMF) Specialist supports the Project Management team in successful execution of setup, maintenance, Quality Control (QC) review, and delivery of TMFs.
What You'll Do Here

• Assist Project Managers (PM) in drafting, reviewing and finalizing TMF Plans
• Manage and coordinate the setup of TMF databases for electronic TMFs
• Collate and index essential documents according to each study’s TMF plan index
• Ensure documents filed in each TMF comply with SOPs, ICH/GCP and other regulations
• File documents in designated TMF sections and maintain each TMF to ensure inspection readiness
• Perform and properly document QC reviews according to project-specific TMF plans
• Liaise with department leads to resolve issues and obtain missing documents
• Setup, maintain, finalize, and deliver paper TMFs, as needed per project scope
• Complete administrative tasks (e.g. status reports, trackers, metrics for client meetings), as requested
• Maintain effective and efficient communication with internal and external stakeholders
• Work with Quality Assurance to ensure GxP and regulatory compliance is maintained
• Provide training and support, as requested by management, to junior TMF Specialists
• Participate in client audit meeting
• Participate in Lessons Learned meetings

What You'll Need to Succeed

• Bachelor or higher level degree (prior TMF experience will be considered in lieu of college degree).
• Quality Improvement

Improves processes and practices by identifying inefficiencies and redundancies; Demonstrates efficiency and quality in one’s own work; Manages and sustains change initiatives.

• Stewardship

Uses available resources effectively and efficiently; Protects physical and intellectual property; Leverages resources for optimal outcomes; Actions consistent with the company policies.

• Accountability

Accepts full responsibility for finding solutions to problems; Takes ownership in the mission of the company and understands role in employee success and satisfaction.

• Communication

Expresses thoughts clearly and respectfully both orally and in writing; Demonstrates effective listening skills; Clearly understands instructions and conveys information effectively; Fluent English language skills required (both written and spoken).

• Service

Provides helpful, courteous, accessible, responsive, and knowledgeable services and information; Addresses employee, management, and/or client questions and concerns in a timely and responsive manner; Demonstrates flexibility.

• Strategy

Ability to work independently; Monitors and re-evaluates decisions and priorities. Identifies and focuses on the most significant priorities;

• Software: Microsoft Office, familiarity with electronic TMF systems preferred.

What We Offer
Benefits
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences’ Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable

Altasciences’ Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program
• Annual Performance Reviews

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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!

Health insurance, Dental insurance, 401(k), Paid time off, Vision insurance, 401(k) matching, Bereavement leave, Referral program