Job Title: Clinical Supplies Manager (2 Openings)
FLSA Status: Exempt
Job Number: 14260807 & 15260807
Department: Chemical Operations
Description:
The clinical supplies manager coordinates activities between contract organizations and Arena's Quality, Regulatory and Pharmaceutical functions to ensure timely delivery of drug compounds for all clinical trials. The successful candidate is responsible for organizing the delivery of clinical supplies for multiple projects, overseeing appropriate labeling and packaging issues, the distribution and reconciliation of clinical supplies with CROs to meet study and GMP requirements, and facilitates the timely arrival of supplies at testing sites. This key position will work with project leaders, and develop timelines and monitor progress of projects, while keeping in contact with both internal and external clients, with regards to updates etc. Develop and implement best practices to improve the work system as appropriate. Maintain and continuously update inventory reports on projects both internally and at CROs. Provide product information to project teams related to product lot, lot status, quantity and expiry/re-test dates. Manage both domestic and international transportation of bulk and clinical supplies. Reconcile clinical supplies, and coordinate destruction of products.
Essential Duties and Responsibilities:
- Evaluate and define the needs for each clinical trial across multiple programs
- Critically evaluate proposed clinical timelines in light of ability to deliver clinical materials
- Propose timelines for clinical supplies, review/edit batch records for supplies, and track retest dates for materials
- Some travel required
Job Requirements:
Education: MBA w/ BS in Chemistry, Pharmaceutical Sciences or a related field and a minimum of 5 years of relevant experience within the pharmaceutical industry.
Experience: Experience with clinical trials and manufacturing of drug products.
Specific Skills: Knowledge of basic pharmaceutics principles and an understanding of the roles clinical operations, formulations and quality plays in designing a successful clinical trial. In depth knowledge of GMP regulations. Excellent time organization and communication skills.
Supervisory Responsibilities: Yes
Physical Demands/Work Environment: Usual office environment including keyboarding/writing (40%) telephone (20%), misc. paperwork, employee interaction, filing, and other office machines (40%); sitting (60%); standing/walking (35%); bending/lifting (5%). Percentages are approximate.
