Manager, Sample Management
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Job Location:
Overland Park, KS - USA
Monthly Salary:
Not Disclosed
Posted on:
6 days ago
Vacancies:
1 Vacancy
Job Summary
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 youre a recent college graduate or seeking your next career opportunity its 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 Youll 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 Youll Need to Succeed
Bachelors 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
#LI-AN1
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!
Required Experience:
Manager
About Company
Contract research organization specialized in seamless, end-to-end, early phase drug development, we act to get your most promising compounds into and through early phase clinical trials.
