- Experience: 5+ years clinical supplies project management experience in the Pharmaceutical Industry.
- Major Responsibilities:
- Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity
- Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
- Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
- Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
- Develops protocol specific labeling compliant with applicable global regulations.
- Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
- Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
- Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages
- Critical Success Factors:
- Understanding of clinical development and global supply chain requirements.
- Competent in the application of standard business requirements (for example SOPs, Global Regulations).
- Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
- Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
- Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.
- Ability to manage and prioritize multiple tasks.
- Project Management skills.
- Good communication skills (both written and oral).
Clinical Supply Project Manager - North Chicago, United States - Spectraforce Technologies
Description
Job Title:
Clinical Supply Project Manager
Location:
Remote
Duration: 12 months
Minimum Pay rate:
$65 an hour (Negotiable)
Established in 2004, SPECTRAFORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US.
The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I.
proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams.
We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India.
SPECTRAFORCE is built on a concept of "human connection," defined by our branding attitude of NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential.
Our entire workflow and teams are trained to cultivate the joy of NEWJOBPHORIA with candidates and employees throughout their engagement with SPECTRAFORCE.
Benefits:
SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances.
Additional benefits SPECTRAFORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program.
SPECTRAFORCE offers unpaid leave as well as paid sick leave when required by law.Equal Opportunity Employer:
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws.
Please contact Human Resources at if you require reasonable accommodation