Data Control Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

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

Education: BA/BS from an accredited college or university. Proficient computer skills, particularly Microsoft Office.

Compensation and Benefits

The salary range estimated for this position based in New York is $59,400.00–$79,200.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: