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.
-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