Job Description

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 Manager, Sample Management will ensure tasks performed are conducted within compliance of study protocol as well as Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic sample processing in accordance with Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs).

What You'll Do Here

• Time & Attendance (timesheet approval, vacations, attendance issues, etc.)

• Staffing (scheduling, strategic workforce planning, participating in the recruitment process

• Performance Management

  • Maintain training records as well as seek out development opportunities for staff.

  • Conduct annual review sessions.

  • Ongoing performance feedback sessions.

  • Work with human resources to address performance and/or behavior-related concerns and, administer corrective actions up to and including terminations.

  • Provide KPI documents to the site Senior Director, Clinical Operations.

  • Attend external training sessions/seminars for personal development.

• Ensure confidentiality of clinical trial participants/sponsors and maintain high level of customer service and quality.

• Assist in sponsor visits and regulatory audits.

• Investigate deviations and resolve data queries that occur in a Note to File, Administrative Memo, CAPA or otherwise.

• Monitor lab equipment daily for proper functionality and escalate any critical observations/findings immediately for resolution.

• Respond, inspect, resolve REES monitoring system calls/notifications, and escalate as applicable.

• Delegate newly awarded studies as well as participating in SOP, protocol, and lab manual/sample processing instruction reviews.

• Perform sample management duties as needed, including but not limited to, routine audits for study start-up and post-study activities, sample handling/processing, sorting, and shipping, lab- supply inventory maintenance (contents of both freezers and refrigerators, etc.) as well as any other duties necessary.

• Communication

  • External Vendors (i.e., shipment couriers, central lab).

  • Governing Bodies (address any deviations resulting from onsite inspections).

  • Management Teams (status of biological samples, etc.)

  • Departmental Supervisors and Staff (communicate issues and/or problem resolutions, etc.)

  • Hold meetings with department staff to communicate clinical trial needs and/or departmental objectives.

What You'll Need to Succeed

• Bachelor’s degree or higher in a field related to health science, preferred.

• Current IATA Certification, required. (Can be trained in-house)

• Clinical research lab experience, 2-year, minimum

• Requires a thorough knowledge of the:

  • Drug development process

  • Clinical trial management

  • Clinical monitoring

  • FDA regulations and ICH Guidelines

  • Knowledge of the EU Clinical Trial Directive is a plus

What We Offer

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

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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!