Clinical Study Manager

Purpose and Scope :

Responsible for planning, coordinating, and managing clinical trial material (CTM) activities for various global clinical supply programs. Monitors inventory and evaluates trends. Summarizes and presents information to teams and management and readily coaches others using expertise. Lends experience for the betterment of the department and manages complex supply chain issues.

Responsibilities and Accountabilities :

Attends clinical study team meetings and proactively develops packaging and labelling solutions and documentation to support the lifecycle of clinical studies for multiple complex programs with a low level of oversight.

Produces detailed plans including budgets, forecasts, and timelines, and is responsible for ensuring timelines are met. Executes on compound / drug related supply chain activities including packaging, labelling, and distribution documentation with first-pass quality.

Plans and monitors packaging and distribution activities and provides input and solutions for

continual improvement and implements suggested improvements. .

Establishes and closely monitors project budgetary spend and looks for areas of cost optimization.

Supports staff development through coaching on process knowledge. Serves as a consultative resource in review of staff documentation and provides instruction for improvement.

Responsible for implementing departmental solutions and may lead efforts to implement new processes.

Represents function on cross-functional improvement teams and communicates progress to

staff on regular basis.

Required Qualifications :

B.S., M.S., Ph.D. in Pharmacy, Chemistry, or other life sciences.

Minimum of 6 years relevant experience or 4 years with an advanced degree.

Demonstrated skills in process and documentation review and improvement.

Excellent communication, collaboration, problem solving, organizational, and strategic thinking skills.

Demonstrates leadership skills including ownership, independent work, and a passion for identifying needs and leading solution resolution activities.

Experience in the application and interpretation of cGMPs, GCP and / or GLP requirements to pharmaceutical development processes. Understands related industry practice in other regions.

Proficient in MS Excel / PowerPoint / Word / MS Project.

Preferred Qualifications :

Experience in clinical supply, supply chain, or clinical / technical planning and operations.

Knowledge of global development considerations related to clinical trial materials.

Experience in leading improvement initiatives.

Staff management experience.