sr. manager, clinical supplies.

job summary:
Sr. Manager, Clinical Supplies (Oral Solid Dose)

6 Month Contract (may extend or convert)

Remote (75%) + 1 week / month in South SF

Looking for West Coast Based Candidates (travel reimbursed)

Must Have:

• Experience with oral tablet dosage form
• Phase 1 & Small Biotech experience
• APAC logistics experience is a plus
• Strong MS Excel skills

Seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. This role is responsible for forecasting Investigational Product (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Collaborates and interacts internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC

and externally with Clinical Service Providers (e.g., CROs, IP Drug Depot).

 
location: South San Francisco, California
job type: Contract
salary: $75 - 95 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• Manage all aspects of IP supply planning and logistics, to ensure alignment with study plans, timelines, budget, and overall clinical development plan.
• Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
• Manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
• Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Assists the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists

 
qualifications:
Required:

• BA/BS required, preferably in a scientific discipline. Other BA/BS degree with clinical supply experience will be considered.
• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management in a small biotech-type of environment.
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies required
• Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred
• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
• Experience in forecasting, labeling, and distribution in clinical environment
• Phase one study experience (FIH, Single Center, etc.) preferred.
• Understanding and proven experience in IRT/RTSM,
• Clinical Supply and similar vendor management experience
• Knowledge of import/export policies

Core competencies and skills

• The ability to prioritize and handle multiple activities on a daily basis while being flexible and responsive to frequently shifting priorities
• Demonstrated ability to integrate into a partially remote team environment (US, APAC) with a positive attitude
• Action-oriented with excellent problem-solving skills
• Strong sense of integrity
• Other qualitative requirements:
  
  
  • Organizational skills
  • Result-driven
  • Strategic agility
  • Resilience and flexibility dealing with ambiguity

#LI-AT1

 
skills: Phase I, Clinical Supply Chain, Clinical Trial Supply Strategy

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.