Manage the Cardiac Safety Specialists function to ensure adherence to Standard Operating Procedures, equitable workload distribution, metric performance, data integrity and customer satisfaction through effective global team development

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Meet Cardiac Safety department Key Performance Indicators (KPIs).

• Use metrics to monitor and manage the output and efficiency of the Cardiac Safety Specialists.

• Delegate work and schedule workforce to meet turnaround and project deadlines.

• Ensure departmental compliance in completing all Training Activities within the allowable timeframe.

• Complete all departmental CAPAs within the allowable timeframe.

• Report to the Director of Operations regarding the conduct, efficiencies, and metrics for department performance.

Manage and improve department Standard Operating Procedures (SOPs) and Standard Work Instructions (SWIs), and promote excellence in Clario standards. Monitor team activity and performance to enforce:

• Strict adherence to study specific and departmental SOPs and SWIs.

• Regulatory compliance, good clinical practices (GCP) and general data protection regulation (GDPR).

• Standardized tracking of departmental metrics.

Ensure the highest standards of data integrity.

• Work with the departmental leads to provide detailed and regular feedback to each employee 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 the global Cardiac Safety Operations team to maintain progressive and effective training programs.

Promote a customer focused environment.

• Monitor workflow to ensure fulfilment of contracted turnaround time.

• Provide timely data review and reconciliation to meet data send timelines.

OTHER DUTIES AND RESPONSIBILITIES:

• Conduct monthly global operations team meetings with leads and seniors to develop and review workload projections, global CS scheduling and capacity planning, workflow processes, equipment/system issues and SOPs/SWIs. Provide documentation of these meetings to the Director of Operations.

• Participate in Project Assurance meetings including; Client Kick-Off, Planning and Start-Up Meetings as necessary. Provide guidance and support to project management in the set up and execution of studies as requested.

• Provide cross departmental training on operational products and workflow processes as needed.

• Participate in service touch point meeting as needed promoting inter-departmental collaboration, a positive team environment, effective communications, and efficient use of resources to meet contract deadlines and to ensure CS compliance with Regulatory guidelines.

• Responsible for the compilation and global coordination of CS schedules including; daily, weekend and holiday coverage.

• Implement strategies that ensure employee satisfaction, career advancement, and competitive hiring practices. Recognize exceptional employee performance.

• Participate in Cardiac Safety Product Management New Product Initiatives assign staff to participate in product evaluation and UAT/validation testing as needed.

• Work cross departmentally to implement Operational Readiness Plans in support of Cardiac Safety New Product Initiatives.

• Provide site operational overview tours as requested to auditors and/or potential clients.

• Establish, track and monitor direct reports progress towards the fulfilment of personal goals.

• Take on additional local level responsibility as and when required, i.e. participation in local leadership meetings.

QUALIFICATIONS AND SKILLS NEEDED:

• Demonstrated technical competency in cardiac rhythm recognition, basic cardiac anatomy and physiology, Interval Duration Measurements (IDMs), Holter arrhythmia and Ambulatory Blood Pressure Monitoring.

• Bachelor Degree in science or equivalent combination of education and experience required.

• Experience in the pharmaceutical field (or related industry experience), with an emphasis in operational management.

• Minimum of five years of progressive management experience.

• Completion of core managerial competencies essential.

• Proven leadership skills.

• Basic computer competencies to include Microsoft Outlook, Word, Excel and data base management.

• Excellent organizational and interpersonal skills.

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.

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. Clario reserves the right to amend or change this job description to meet the needs of Clario.This job description and any attachments do not constitute or represent a contract.

The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.