Clinical Supply Chain Manager
- Waltham, MA
Site Name: USA - Massachusetts - Waltham
Posted Date: Jun 16 2020
Are you looking for a high-profile supply chain leadership role that allows you to accelerate efficiency and global product delivery? If so, this Supply Planning Manager role could be an ideal opportunity to explore.
As a Supply Planning Manager, you will plan and execute activities to deliver Clinical Trial Materials (CTM) in support of GSK's global clinical programs. Work internally with Clinical Operations, Quality, Regulatory, Medical Affairs and CMC teams and externally with third party procurement, packaging, labeling and distribution providers to align objectives, timing of deliverables and provide information and recommendations to drive decision-making related to clinical supply.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Ensures that key project milestones are met; negotiates and communicates clinical supply plan timelines to internal and external stakeholders and partners.
- Obtains necessary data through partnering with Clinical team members to determine CTM needs based on established GSK protocol(s).
- Collaborates with Clinical team to create supply scenarios that provide CTM options to meet clinical plans and implement endorsed strategies.
- Manage sourcing of comparators with third parties as needed to support studies.
- Reviews and approves pre-and post-production documentation of clinical supplies (including but not limited to label creation, generation of packaging requests, batch record review, and coordination with GSK QA for release of CTM).
- Interface with Qualified Person to enable release of CTM.
- Manage logistics of CTM inventories across depots and CTM distribution from depots to investigator sites. Including oversight of import and export logistics for CTM including coordination of import permits and review of documentation
- Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing, release and maintenance to support randomization and management of CTM across all studies.
- Collaborate on pharmacy manuals and patient instructions with Clinical Operations.
- Manage CTM inventory for duration of studies including shelf-life and expiry dating, coordination of retest extension, response to temperature excursions, and management of returns for destruction from investigator sites as needed.
- Support GSK QA in the investigation of product complaints.
- Manage study/program budget, contracts and change orders and track spend against budget for assigned projects.
- Regularly meet with manager to report challenges and risks and propose resolutions.
We are looking for professionals with these required skills to achieve our goals:
- BS/BA or equivalent and 4+ years of related experience.
- Experience in CTM planning and execution.
- Understanding of relevant FDA/EMA/ICH GXP quality requirements.
- Experience managing IRT systems and their setup.
- Experience with management of temperature controlled shipments.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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