Job Title: Data Management Lead (Medical Affairs)

Location: Fully Remote (US based) Must be able to accommodate West Coast hours.

About Us: At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!

Key Responsibilities:

Cross-functional Data Management Leadership:

• Manage and coordinate the integration and utilization of all ancillary systems.
• Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
• Review and analyze metrics to derive meaningful summaries of study health and trends.
• Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
• Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.

Bid Pursuits and Proposals:

• Support experienced Data Management Leads in bid pursuit preparation meetings.
• Provide input on Data Management slides as appropriate.

Project Quality Management and Compliance:

• Ensure compliance with Standard Operating Procedures, ICH/GCP Guidelines.
• Maintain inspection-ready Trial Master Files.
• Identify and address quality issues, ensuring they are raised in relevant systems and closed according to requirements.
• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.
• Support and implement corrective/preventive actions for studies.

Project Financial and Resource Management:

• Ensure appropriate project-level resourcing of staff and staff assignments.
• Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
• Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.

Company Initiatives:

• Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
• Support other functions by providing meaningful feedback on initiatives.
• Ensure Parexel-requested information entered into management systems is accurate and regularly updated.

Training:

• Maintain training compliance as per job roles assigned, including on-the-job training.
• Deliver project-specific training to internal Data Management teams.
• Address training needs based on identified development goals.

Skills and Qualifications:

• Ability to lead and collaborate with global teams, motivating and guiding virtual teams across multiple time zones and cultures.
• Strong negotiation skills and the ability to influence to achieve mutually beneficial results.
• Excellent interpersonal, oral, and written communication skills, using concise phrasing tailored for the audience with a diplomatic approach.
• Learning ability and knowledge-sharing approach; swift understanding of technologies and new processes.
• Flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.
• Basic presentation skills.
• Customer focus to interact professionally and respectfully within Parexel and with all external colleagues to build rapport and trust.
• Commitment to first-time quality, including a methodical and accurate approach to work activities.
• Strong time management and prioritization skills to meet objectives and timelines.
• Evidence of strong problem-solving skills, including the capability to make appropriate decisions in ambiguous situations and conduct root cause analyses.
• Ownership and accountability relative to key accountabilities in the job description.
• Ability to travel as required.
• Written and oral fluency in English.

Knowledge and Experience:

• Experience in the clinical research industry or a similar field.
• Proven record of coordinating and supporting project teams.
• Basic understanding or willingness to learn and apply Parexel financial tools, reports, and processes for managing project financials regarding forecasting, revenue recognition, scope of work, and department budget for assigned projects.
• Basic understanding of or willingness to learn Clinical Study Team roles outside of Data Management.
• Full understanding of or willingness to learn and apply relevant ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study-specific procedures.
• Awareness of or willingness to learn SDTM/CDISC/CDASH standards.
• Awareness of or potential prior experience in Clinical Trial/Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
• Demonstrates technical aptitude.

Education:

• Must have a minimum of a Bachelor’s degree and/or other qualifications in a science or clinical-related industry.