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

Reporting to the Senior Director, IT & Strategic Planning, the Technology Onboarding Specialist is responsible for evaluating and establishing recommended configurations and usages for new technologies. Working closely with the users, the validation group as well as IT in general, the Technology Onboarding Specialist will help in the configuration of applications and systems to ensure that they work optimally within the Altasciences environment. This will include solid documentation on the installation and configuration to ensure a smooth handoff to the users as well as IT support and validation as may be required. The Technology Onboarding Specialist has extensive experience in multiple different types of software as well as software interactions with systems and general application interoperability. The Technology Onboarding Specialist will also assist in determining the best deployment method for the new technology as well as establishing SOPs and other instructions or guides as may be required.

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)
Fluent English language skills required (both written and spoken)
Software: Microsoft Office, familiarity with electronic TMF systems preferred

What We Offer

The pay range estimated for this position is $50,000-$65,000 annually. Please note that hourly rates/salaries vary ,within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data.

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

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!

Altasciences jobs

TMF Specialist