Manager, Clinical Data Management
India, Remote求人ID R0000033121 Category Data Management
About this Role
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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