ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
ERT Boston is looking to hire a Manager, Data Coordination to ensure adherence to Standard Operating Procedures, equitable workload distribution, acceptable metric performance, data integrity and customer satisfaction through effective global team development.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Meet department productivity targets.
- Ensure the department is adequately staffed and trained globally in order to maintain workflow and meet contractual turnaround deadlines.
- Review team metrics with senior management to monitor and manage the output and efficiency of the Data Coordinators.
- Delegate work and organize staff to meet turnaround and project deadlines.
- Monitor ERT Systems to ensure consistent daily workflow.
- Determine hiring projections and strategies.
- Ensure the job responsibilities of the Data Coordinator function are performed daily and that backup support is available if staff is away from the office.
- Support implementation of new data systems, technologies, and methods including participating in project teams, establishing user requirements, creating SOPs, and completing all necessary training and proficiency testing.
- Promote inter-departmental collaboration to support customer satisfaction and efficient use of resources to meet contract deadlines.
- Ensure adherence to global SOPs and SWIs.
- Recommend and implement process improvements.
- Keep all SOPs and SWIs up-to-date.
- Author and implement study-specific SOPs.
- Work closely with management teams of other departments to improve processes and maintain adequate workflow through ERT systems.
- Meet with Cardiac Safety Operations and Project Management to review delivery schedules for bulk, retrospective and Thorough QT studies.
- Ensure adequate staff coverage for data entry, digital resolution, data verification and query resolution for studies. Organize global assistance or temporary staff reallocation as necessary.
- Serve as the point person for issue resolution involving Operational teams.
- Coordinate the marking of beats with CSS for Digipad analysis.
- Handle Holter reports and TAT issues.
- Compile TAT metrics.
- Manage workflow by sponsor, account and TAT.
- Monitor miscellaneous charge accounting
- Oversee archiving of paper files.
- Ensure maintenance and filing for paper source documents
- Ensure the highest standards of staff performance and data integrity.
- Provide detailed feedback to employees and management regarding performance success and improvement needs.
- Utilize data/process checks and QC/QA trends to organize corrective action and maintain standards.
- Ensure that staff training supports excellence in work conduct and performance. Work closely with training team to maintain progressive and effective training program.
- Participate in Project Assurance meetings including; Client Kick-Off, Planning and Start-Up Meetings as necessary.
- Participate in monthly Interdepartmental Meetings supporting inter-departmental collaboration to promote DC services, a positive team environment, effective communications, and efficient use of resources to meet contract deadlines and to ensure DC compliance with Regulatory guidelines.
- Oversee the maintenance of training logs for all employees.
OTHER DUTIES AND RESPONSIBILITIES:
- Other related duties and projects as assigned.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
- BS or BA degree in life sciences or related field with 4+ years prior supervisor experience
- 5+ years’ experience in Data Coordination or related department with progressive responsibilities in staff mentoring and supervision.
- Proven leadership skills.
- Computer competencies to include Microsoft Outlook, Word, and Excel.
- Excellent organizational and communication skills.
- Ability to implement systems and processes to accommodate departmental needs.
- Ability to react quickly to an ever-changing environment with excellent problem solving skills.
- Proactive in proposing process improvements.
- Ability to travel.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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