- Posted 30 November 2022
- Salary US$32 - US$42 per hour
- DisciplineLife Science
- Contact NameColin Murray-Bain
Contract Length: 12 Months
Pay Rate: $32-42/hr
Clinical Project Manager - Clinical Supply Chain
- Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy
2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:
- Drug discovery (eg, Process Chemistry, Analytical Chemistry)
- Drug development (eg, Formulation)
- Clinical operations (eg, Clinical Project Management)
- Supply chain (eg, Clinical Supplies Project Management)
- Quality Assurance
- Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials
- 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 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).
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.