Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position Summary:
To manage the receipt, processing and control of data for CTD Global depots.
Essential Duties and Responsibilities:
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Manage receipt of randomization data in accordance with FCS SOPS.
- Review and update randomization date to ensure compliance with formatting requirements in accordance with FCS SOPs and policies.
- Provide guidance and verification for third party patient randomizations and material lists.
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- Teams with Cenduit for randomization and material list generation.
- Update SOPS as required for evolving processes.
- Review and approve PASS Definitions to allow accurate barcode scanning in Operations.
- Maintain data in FCS Systems for use by other departments.
- Provide data related process support for GPM/PASS to all departments.
- Maintain sufficient knowledge of other department's processes, procedures and policies to support their data requirements.
- Provide training to other departments or sites as required.
- Establish processes and communicates with new and existing depots globally.
- Collaborate with IT/IS to assist in resolving Operations, Inventory and Distribution issues.
- Participate in User Acceptance Testing, when required, for upgrades to GPM/PASS.
- Participate in User Acceptance Testing, when required, for new automated labeling/data equipment.
- Communicate effectively with all levels of employees/management on all data related issues.
- Obtain sufficient knowledge of TrackWise and perform assigned tasks within it as requested.
- May be required to participate on a project team within the department, or in conjunction with other departments.
- May be required to attend Client audits to provide information on Data Control process and procedures.
- May be required to train new hires or back-ups on Data Control processes and SOPs.
- Conducts all activities in a safe and efficient manner.
- Other duties may be assigned to meet business needs.
Basic Minimum Qualifications (BMQ):
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
Education/ Experience (BMQ):
BA/BS from an accredited college or university. Proficient computer skills, particularly Microsoft Office.
Ability and/or Skills (BMQ):
Strong organizational skills, problem solving, attention to detail and PC skills required. Experience with Excel, Access and GPM a plus