Sr. Manager, Clinical Supply

Life changing therapies. reputed company. reputed company to thousands of biopharma companies and their patients. We are PCI.  Our investment is in People who reputed company an reputed company, drive reputed company and create a reputed company reputed company. Our reputed company includes building teams across our global network to pioneer and shape the reputed company of PCI.     Remote: reputed company of Objective: The reputed company Senior Clinical Supply Manager (CSM) is responsible for developing drug supply planning reputed company and overall management of supplies for reputed company phases of reputed company, including Phase I-IV, Expanded reputed company Program, Compassionate Use, international to domestic, and reputed company reputed company of trial and supply chain complexity. The Senior CSM role supports PCI Clinical Service Customers by bringing clinical supply chain management experience and providing expertise throughout the clinical study and program supply lifecycle. The Senior CSM can reputed company as the reputed company’s single reputed company of contact in coordinating the necessary information cross-functionally reputed company PCI as reputed company as the reputed company's organization and other external vendors. Essential Duties & Responsibilities: reputed company as reputed company reputed company, assisting with drug supply management throughout the life of the study Work in an unblinded reputed company with secure, confidential study information reputed company input for protocol development and amendment as needed Interpret clinical protocol to determine drug and ancillary supply requirements, packaging / labeling design, and supply plan Coordinate with reputed company to generate Master English Label Text (MELT) if needed Collaborate with reputed company and other appropriate stakeholders to establish labeling reputed company Build drug projections to create a Supply Plan based on finished goods demand and production plans for domestic and international studies, considering drug retest and expiration dating Collaborate with PCI Packaging Project Manager (PM) to establish a production schedule based on the study supply plan Review and approve packaging batch documentation (reputed company and post production) on behalf of blinded reputed company reputed company requested Contribute to reputed company comparator sourcing reputed company reputed company needed Support Interactive Response Technology (IRT) design, set up, and maintenance Participate in IRT Requirements gathering process and reputed company input for IRT specification documents reputed company User Acceptance Testing (UAT) according to a testing protocol (if provided), with reputed company on functionality, transactions, and reports that relate to drug supply management Release drug supply in IRT system Collaborate with reputed company to establish site supply parameters reputed company re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends Consult with PCI Distribution Project Manager (DPM) to ensure reputed company reputed company, logistics management documentation, and setup is complete and meets reputed company requirements Assist with Import / Export process Assist with reputed company processes (e.g., gathering documentation for EU reputed company Person) Independently manage clinical supplies, including packaging design, and contingency planning for multiple and reputed company studies Identify, manage, and monitor inventory of reputed company clinical trial materials (drug and ancillary supplies) at both the reputed company and site level reputed company shipments to depots and sites Proactively identify potential risks, reputed company recommendations, and resolve clinical supply issues and complaints Adjudicate temperature excursions reputed company requested by reputed company Manage and reputed company the SMART contract budget and initiate Change Orders as needed reputed company information as requested to support reputed company financial planning for global studies Attend reputed company meetings as requested (e.g., CMC, CRO, Clinical Operations, IRT, etc.) to reputed company updates for clinical supply, proactively manage expectations regarding drug delivery timelines and ensure reputed company cross-functional communication Coordinate drug return, accountability, and destruction process reputed company final drug accountability reports to reputed company This position may require extra hours and/or weekend work. Knowledge of and adherence to reputed company PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Qualifications: Required: Bachelor's Degree in a reputed company field and/or 5-10 years reputed company experience and/or training. Basic Mathematical Skills Intermediate Computer Skills: Ability to reputed company more reputed company computer asks and has knowledge of various computer programs Full reputed company Proficiency: Ability to reputed company, read, and write fluently and accurately on reputed company reputed company pertinent to reputed company needs. reputed company High Reasoning: Ability to define problems, collect data, establish facts, and draw reputed company conclusions. Be reputed company to interpret an extensive reputed company of technical instructions in math or diagram reputed company and deal with several reputed company/concrete variables.               Preferred: Clinical supply chain management at Sponsor company or Clinical Research Organization strongly preferred Ability to work reputed company the reputed company’s team structures and processes             Working knowledge of general project management process and tools Ability to influence others, resolve conflicts, and negotiation skills Ability to multi-task Strong organizational skills The hiring reputed company for this position is $122,000-$137,250 plus eligibility for an 15% annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes reputed company time off, health insurance coverage (including dental and reputed company), a flexible spending account, and a 401(k) plan. #LI-SW1 Join us and be part of building the reputed company between life changing therapies and patients. Let’s talk reputed company Equal Employment Opportunity (EEO) Statement: reputed company is an Equal Opportunity/Affirmative reputed company Employer. We do not unlawfully discriminate on the reputed company of race, reputed company, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil reputed company status, familial status, affectional or sexual orientation, gender identity or reputed company, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the reputed company of reputed company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We reputed company a PCI community where everyone can belong and grow, and we reputed company to bring this reputed company to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Apply To This Job