Almac Group is currently seeking an Investigational Product Lead (IPL) role for our Durham, NC location. The Investigational Product Lead will provide investigational product (IPL) oversight to investigator sites and ensure optimal clinical trial conduct with regards to IP. The IPL will work closely with the following roles to resolve IP matters; Investigational Product Pharmacist (IPP), Clinical Research Associates, Clinical Trial Managers, sponsor study management team, Supply Chain Leads and Interactive Response Technology (IRT) specialists.

The IPL will support the IPP by providing enhanced monitoring of the daily clinical supply activities at their assigned investigator sites to ensure availability of IP for subject assignment and dosing. Areas of focus include IP shipments, temperature excursions, IRT activities, inventory monitoring, inspection preparation and IP reconciliation. The IPL will provide this support for multiple sites and multiple protocols concurrently.

Responsibilities include but are not limited to:

Communicate with clinical sites to verify accurate investigator site contact information, receiving hours, IP storage capacity and maintain updates to all contact information. Support sponsor study team in the collation of information for pre-trial assessments.
Monitor usage of site inventory through reviews of study documentation, including but not limited to, IP shipment documents, inventory dashboards, IRT reports, data visualizations, and investigational product accountability logs/forms. Escalate potential shortages and/or issues to the appropriate study team contact.
Oversee the end-to-end distribution of clinical supplies to investigator sites from Almac and other contract manufacture organizations. Notify sites of upcoming IP shipments. Monitor the delivery and receipt of shipment to ensure IP is on site and available for dosing. Escalate any distribution issues to the internal and/or external study teams to facilitate resolution in a timely manner.
Communicate effectively across internal and external teams to support the resolution of temperature excursion assessments and IRT discrepancies and queries.

Qualifications:

Required Experience / Education:

BS degree or 5 years relevant experience in a similar role
Solid working knowledge of Microsoft office products (e.g., Excel, Word, Teams, Outlook)

Preferred Experience / Education:

1 year of general relevant work experience
1+ year working with clinical sites or investigational protocols.
1+year clinical research/clinical trial experience
1+year working with rapid enrolling studies.
Pharmaceutical industry experience

What can Almac Group offer you?

Medical, Vision & Dental benefits from the 1st of the month following start date
20 days PTO per year, accrued monthly following start date
12 holidays per year
Work from home schedule available after 6 months if role allows
Company paid Long and Short-term disability along with Life Insurance
401k company contribution
Professional development programs/ continuous learning opportunities

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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 6,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.

Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

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Average Compensation: $109,512

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