Manager, Sample Management

CareAbout•Overland Park, KS

About The Position

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).

Requirements

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

Nice To Haves

Knowledge of the EU Clinical Trial Directive is a plus

Responsibilities

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.