Manager, Clinical Data Management

Team Leadership
• Ensure team delivery of high-quality project deliverables by monitoring performance
• Train and mentor team according to job role expectations, acting as an SME for a functional process or account as applicable
• Meet with full team on a regular basis with comprehensive communication

and guidance
• Conduct individual 1:1s with all staff on a regular basis
• Awareness around team performance and impacts to accounts team is contributing to, collaborate with Account Lead colleagues where AL is not LM
• Promptly deliver positive and constructive feedback to team members

Account Leadership
• Point of contact for clients and within Parexel for account specific matters requiring escalation to senior management
• Proactively identify potential issues/concerns related to DM on the account that may adversely affect strategic partnership with the client and communicate those to senior management for preemptive measures
• Establish effective working relationship with Biostatistics Account Lead on

mutual accounts
• Maintain seamless communication with the account staff to ensure study/project progress, timelines, quality, budget and all the deliverables are being met with quality
• Implement strategies for the maintenance and growth of the partnership to ensure that deliverables are of high-quality including representation and successful support for bid pursuit meetings
• Own and maintain partnership training curricula
• Oversee and coordinate the implementation of client processes (if applicable) and optimization of those processes (LMS Review, Training modules creation, maintain SOP list, process update communication, authoring/customizing partnership process documents, mentoring, etc.)
• Assigned as QI manager on partnership QIs
• Work with each regional head and plan for long term recruitment strategy
• Oversee/review resource requirements across the portfolio of studies/projects within a client and communicate with Sr. Management at Parexel
• Collaborate with Project Management Office and Project Quality Lead to oversee/calculate KPI/Metrics for account
• Oversee/review financial score of an account and generate summary table
• Facilitate “Lessons Learned” after project completion and determines improvement opportunities within the Account
• Have regular meetings with direct reports and staff within an account
• Attend regular account oversight client meetings (such as weekly meetings, monthly functional management team meetings, quarterly operational management team meetings, bi-yearly executive steering committee meetings, etc.)

Quality Management Compliance
• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of activities
• Develop team to independent data collection for KPIs, Metrics, dashboards as applicable
• Lead reviews of role specific training curricula – as applicable
• Contribute to Parexel process documents authoring or reviewing
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements and Parexel processes
• Check quality of team deliverables and proper remedial action

Financial Resource Management
• Ensure proper resourcing of team
• Proactively plan and support financial excellence
• Drive team compliance and proper execution of financial reviews
• Provide feedback on team financials and resourcing through collaboration with Subject Matter Experts

Initiatives Business Development
• Lead and/or Contribute to initiatives that requires cross functional collaborations
• Lead and/or Contribute to bid pursuit activities by supporting team and/or attending bid pursuit opportunities
• Lead and/or Participate in Parexel and department system/standards improvement activities

General Activities
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Skills:

The Manager, Data Management position at Parexel requires a diverse skill set across three main categories: Leadership, Personnel Management, and Business Operations.
Leadership Skills:
• Building and leading global (virtual) teams with authority
• Strong negotiation and organizational skills
• Excellent analytical and problem-solving skills
• Excellent communication skills with a diplomatic approach: keen sense of inclusion for colleagues and clients of all backgrounds and perspectives
• Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
• Effective time management to meet objectives
• Demonstrated proactive thought process to minimize and mitigate risk
• Ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development
• Ability to make appropriate decisions in ambiguous situations

Personnel Skills:
• Excellent interpersonal, oral, and written communication skills
• Ability to gain trust and confidence with a variety of clients as well as within Parexel
• Excellent learning ability
• Strong managerial courage, resilience, and ability to adjust to a rapidly changing environment
• Excellent presentation skills (internal and external presentations)
• Work with integrity
• Competent in written and oral English and local language (as applicable)
• Ability to travel as required

Business Operations Skills:
• Experience with one or more EDC platforms (Rave, Inform, Datalabs, etc.)
• Strong commitment to Quality
• Understanding of GDO tasks, specifically within Data Management and Database Programming, regulatory requirements, and data standards
• Ability to identify any bottlenecks during operational processes and bring to the attention of the senior management team at Parexel while, in tandem, providing the client with potential solutions
• Work with clients to finalize Key Performance Indicators (KPIs)/metrics
• Maintain maximum utilization of self and team
• Manage team compliance to SOPs

Knowledge and Experience:
• Strong work experience in similar position
• Acted in a leadership role in their area of expertise
• Proven record of leading project and program teams, previous line management experience is preferred
• Strong understanding of cross functional activities
• Strong patient and customer service focus
• Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures

Education:
• Bachelor’s degree preferably in a science or industry- related discipline or equivalent experience.
• Certification or involvement in a professional society or organization is recommended

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