Clinical Trial Supply Manager

Summary:

The purpose of this position is to manage the distribution logistics for assigned projects in support of the planning, execution, and close out of Phase I - IV clinical studies to ensure the objectives of the studies are met.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed in this role. Other duties may be assigned.

• Manage the distribution logistics for assigned projects.
• Develop and apply the distribution strategy (for IRT and non-IRT studies) that ensures continuity of IP at depots and investigation sites.
• Ensure all critical parameters are considered for every distribution strategy; IRT specifications (e.g., initial or resupply quantities); any QP, project, study, expiry, customs, import/export, brokerage, or country specific requirements.)
• Work with relevant departments to create master labels for each study.
• Ensure adequate stock at depot and site levels.
• Support relabeling activity or transfers between sites.
• Generate and/or review shipment requests for accuracy & completeness prior to issuance.
• Ensure accuracy of IP receipt for all shipments and availability in IRT for applicable studies.
• Serve as point of contact for Returned Product Numbers.
• Ensure that final drug reconciliation is completed and accurate at site and study level.
• Serve as point of contact for all distribution activities.
• Provide adequate communication and documentation relevant to the clinical study plan and the movement of all investigational products.
• Contribute to the budgeting and forecasting for all clinical studies.
• Offer creative solutions/proposals to optimize the clinical supply chain.
• Generate and maintain data for clinical distribution metrics.
• Work closely with Assoc. Dir, Clinical Trial Supply to support on all relevant trials.

Supervisory Responsibilities:

None

Interaction:

The incumbent may work closely with internal Clinical Operations, Data Management, Statistics,

Regulatory Affairs, Pharmacovigilance, and Executive staff, as well as external consultants,

clinical research organizations (CROs), vendors, and clinical site personnel.

Education and Experience:

• Bachelor's degree from an accredited college or university.
• 3-5 years of health sciences experience is required (pharmaceutical industry or related experience is preferred; work in the areas of clinical operations, and/or project management a plus).

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knowledge, Skills, and Abilities:

• Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly.
• Excellent knowledge of clinical study protocols and IP related activities with particular emphasis on global distribution and strategy.
• Thorough understanding of GMP, GDP (IP production and distribution).
• Thorough understanding of IRT systems.
• Good understanding of CMC and clinical study conduct activities.
• Excellent ability to interface with customers and distribution partners (couriers, brokers, vendors).
• High attention to detail.
• Strong problem-solving skills.
• Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization, effective time management skills.
• Exercises calm, sound constructive judgment during high demanding situations.
• Proficiency using Microsoft Outlook, Word, Excel, and PowerPoint.
• Excellent oral and written English communication skills.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse. Will need to lift and move items weighing up to 20 pounds.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The work setting consists of a typical pharmaceutical office environment with offices and cubicles.

• Medical, Prescription, Dental, Vision Coverage
• Flexible Spending Account & Health Savings Account with Company match
• Employee Assistance Program
• Mental Health Resources
• Disability Coverage
• Life insurance
• Critical Illness and Accident Insurance
• Legal and Identity Theft Protection
• Pet Insurance
• Fertility and Maternity Assistance
• 401(k) with company match
• Flexible Time Off (FTO) and 11 paid holidays
• Paid Parental Leave

The base pay range for this role is $102,000 per year to $141,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.