Clinical Project Manager

Job Description

Job Description

Description:

• Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials.

• Duties include: 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.

Qualifications:

• Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.

• Experience: 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

• 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).

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities