Manager for Sample Management Department

Alliance Pharma, Inc. is a contract research organization (CRO) specializing in advanced bioanalytical and drug metabolism services.

Manager – Sample Management Department

We currently have a position open for Manager of the Sample Management Department in our laboratory in Malvern, PA.

The Manager is responsible for all operational activities associated with the implementation, maintenance and ongoing process improvement for Alliance Pharma’s Sample Management operations. The Sample Manager is responsible for collaborating with appropriate cross functional team members to ensure effective implementation and reporting of the Sample Management program.

Roles and responsibilities may include but are not limited to:

1) Process Development, Improvement and Maintenance:

· Support the maintenance of all associated quality documents relative to the SM process to ensure current and accurate.

· Apply knowledge of company SOPs, GLP and GCP regulatory requirements to oversee the receipt, inventory, storage, use, and disposal of study samples accordingly

· Apply knowledge of GLP (FDA, EPA and OECD) and GCP regulations as well as 21 CFR Part 11 (electronic records and electronic signatures) as applicable to the work of the department

2) Training and Communication:

· Identify any training needs and participate in the development of any sustainable training required.

· Support the ongoing review of sustainable training to ensure it is current, accurately reflects the appropriate SM processes and appropriately deployed to the affected departments and job functions.

3) SM Ongoing Support:

· Lead SM activities and support study rollout/implementation planning

· Manage and coordinate study set up in Sample Management system

· Act as liaison between study team and Sample Management

· Collect and maintain lessons learned, challenges, gaps and opportunities to facilitate continuous improvement processes.

4) SM Project Implementation and Metrics Reporting:

· Collect and coordinate identified SM related metrics for reporting to key stakeholders and management.

· Coordinate with other preferred CROs for SM implementations and ensure relevant information is disseminated to project teams.

5) Participate as required in process improvement representing SM.

· Participate in vendor evaluation as required (e.g., new technologies, clinical CRO selection).

· Contribute to various Medical & Development process improvement initiatives and SOP (or other quality document) development.

6) Manage the staff in the Sample Management Group.

· Work with team to develop goals and manage performance

· Participate in hiring as required

· Perform annual performance evaluations and career development of team members

Qualifications and Desirable Skills:

AA, AAS, B.Sc. or equivalent

· Previous sample management experience at a CRO highly considered.

· Bachelor's degree (or equivalent) with scientific or clinical background, study management experience preferred but not required

· 3 plus years related experience in pharmaceutical, central laboratory, clinical research or health services industry with a minimum of 1 years’ experience as clinical study manager, data manager, or project manager.

· Experience with protocol and clinical drug development processes

· Excellent interpersonal, written, and verbal communication skills and computer ability

· Problem solving, critical thinking skills (i.e., Can Identify root cause and propose/implement reasonable corrective actions in the context of Company’s SOPs, protocol, and industry best practices; Able to apply lessons learned from prior experience to novel challenges).

· Proactive thinking skills (i.e., Can anticipate problems and take appropriate actions to avoid them).

· Highly motivated, self-directed (i.e., Ability to work independently); Follow through on commitments.

· Organized (i.e., Aware of status of tasks/milestones of assigned projects and of delegated tasks)

Job Type: Full-time

Pay: $50,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Relocation assistance
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location