CSSM Data Coordinator

Description

DESCRIPTION
Position Purpose The primary role of the CSSM Data Coordinator (CSSMDC) is to support the Supply Chain Lead (SCL) with locating and uploading to the Trial Master File System (TMF) specific study related documents.

Primary Responsibilities:

Makes use of expertise in Clinicopia, M3 GDMS, LIMS and other Supply Chain systems to: locate, extract and upload study specific documents to the Trial Master File System according to Pharm Sci and CSSM responsibility

Technical Skill Requirements:

Ability to learn, maneuver Supply Chain systems

Ability to interpret Supply Chain systems data/output, determine risk and recommend a plan to address

Excel Experience Required

Understands TMF requirements to support Supply Chain Leads.

Qualifications: Training & Education Preferred:

BA degree or equivalent - preferably in the pharmaceutical field, logistics or supply chain

Experience of systems administration, data entry, information management and process, and project management tools

Prior Experience Preferred

Considerable knowledge of interdependencies of supply chain principles, practices and concepts and an understanding of the practices, concepts and operations in other relevant disciplines.

Recognized as an internal expert in their discipline and/or role.

Knowledge of the development process in the Pharmaceutical industry.

Understanding of project management concepts.

Competent in using information systems including MS Office products.

Effective in both verbal and written communication

Ability to multi-task, manage personal time and manage multiple priorities.

Proven ability to influence, negotiate and problem solve.

Demonstrated ability to apply process improvements and procedures

Experience and working knowledge of Clinical Supply Systems

Core Competencies:

Functional/Technical Skills - Knowledge and demonstrated ability to apply technical system skills to projects within Supply Chain Management; including, solid knowledge of TC Visualize, Excel, Microsoft Project, Clinicopia, CSDS, M3, GDMS). Understands GMP/GCP documentation and compliance. Knowledge of TMF process and ability to retrieve all required data. Understands the Drug Development and Supply Chain processes; including study design process and it's relationship with Supply Chain activities.

Peer Relationships - Able to work in a team environment with multiple "customer" (SCLs). Skilled at building relationships within CSSM. Communicates proactively in both written and oral form. Can solve problems with peers with minimum of noise. Encourages collaboration. Can be candid with peers

Seizes Accountability - Comfortable working alone on assignments. Bottom line oriented. Pushes self and others for results. Stand up and be accounted on. Ability to self motivate to resolve and address issues. Ability to understand and proactively analyze system data to be discussed with SCL/customer. Technical/Functional Competencies: Competency Detail/Comments (specific skills, etc.) Technical/Professional Knowledge Analytical and Problem Solving Teamwork/Communication Self-Sufficiency/Autonomy

Knowledge and demonstrated ability to apply technical system skills to projects within Clinical Supply Strategy and Management; including, Excel, Clementine, Microsoft Project, Clinicopia, CSDS, M3, GDMS, LIMS

Understands GMP/GCP documentation and compliance.

Knowledge of TMF study requirements and the ability to retrieve and data.

Understands the Drug Development and Supply Chain processes; including study design process and its relationship with Supply Chain activities.

Flexibly applies technical and problem solving skills to support TMF requirements across a wide range of programs and study designs. Ability to develop efficiencies in an ambiguous and changing environment.

Able to work in a team environment with multiple "customer" (SCLs). Skilled at building relationships within SCM. Communicates proactively in both written and oral form.

Ability to work independently on assignments (ie maintaining TMF required documents, proactively gathers system information to enable SCL support). Manages time well. Is able to prioritize multiple assignments and "customers" (SCLs) concurrently. Utilizes judgment and experience to apply information to assignments.

SKILLS

MS Excel, MS Outlook, MS Word

Synectics is an Equal Opportunity Employer.