WHO WE ARE
Caligor Coghlan Pharma Services, our mission is to partner with pharmaceutical, biotechnology, and medical device clients to help bring new, life changing medical products and treatments to people in need across the world.
We feel good about the work that we do – as a global company, our services include clinical trial design, clinical packaging and labeling, medical product management and global distribution, commercial and ancillary product procurement, Early Access to Medicines services, and strategic regulatory consulting. We pride ourselves in making it our business to find a better way to deliver for our clients - and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day. We expect all of our people to live and work our corporate values of *Integrity*People*Quality*Service*Expertise*Accountability*
If you are looking for a role that supports the types of endeavors listed above in the world of Pharma Services, where what you do and how you do it will make a difference, then this Clinical Supply Project Manager position is for you.
WHAT YOU WILL DO
The Clinical Supply Project Manager plans, implements and coordinates the day-to-day clinical supplies activities for clinical research development programs associated with investigational and marketed drugs. He/she has direct responsibility for day-to-day project planning and implementation of tasks necessary to ensure the successful completion of protocols. These tasks include building a comprehensive project plan, production scheduling, procurement coordination with Commercial team, label design coordination with Operations team, batch record documentation, packaging and distribution protocol creations, invoicing and budget tracking, and client communication and expectation management.
The Clinical Supply Project Manager will ensure protocol-specific objectives, timelines and budget guidelines are accomplished. If variances occur, he/she will immediately report these to the client and process any necessary change orders or amendments to ensure CCPS is being compensated for work performed. He/she works closely with client representatives and site management staff to identify and propose solutions and corrective actions to complex clinical supply problems.
Additional responsibilities involve ensuring tasks and activities comply with current Good Manufacturing Practices (cGMPs) and under CCPS Standard Operating Procedures (SOPs), plan improvement implementations related to clinical supply routine functions, interact with other departments to implement planned improvements.
He/she will be responsible for leading the internal, cross-functional team assigned to each protocol; directs and coordinates the activities of project assigned team members to resolve issues including, labeling, packaging, distribution of clinical supplies, randomization, and drug accountability.
The post holder reports directly to the Senior Global Project Manager – Clinical Supply Services (CSS), but he/she will work closely with the Business Development team, the broader CCPS Commercial team, the CCPS Operations team, and the CCPS QA/QC team.
Qualifications, Experience and Skills Required
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