Data Management Lead I

4 weeks ago

Bloemfontein, Orange Free State, South Africa Parexel Full time
About the Role

Parexel is seeking a highly skilled Data Management Lead I to join our team in South Africa. As a key member of our clinical research team, you will be responsible for providing leadership in all aspects of data management, ensuring the timely delivery of high-quality data to our clients.

Key Responsibilities
  • Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
  • Highlight issues/risks to delivery by understanding interdependencies and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
  • Review and analyze metrics to derive meaningful summary of study health and trends.
  • Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
  • Host and attend cross-functional meetings, prepare Meeting Agendas and Minutes, and comply to action and decision logs.
Bid Pursuits and Proposals
  • Support experienced DML in Bid Pursuit preparation meetings.
  • Provide input on DM slides, as appropriate.
Project Quality Management and Compliance
  • Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
  • Maintain inspection-ready Trial Master File.
  • Identification of quality issues, ensuring they are raised in relevant system 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 study, and work toward alignment across Parexel as appropriate.
Project Financial and Resource Management
  • Ensure appropriate project level resourcing of staff and staff assignments.
  • Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools.
  • Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.
Company Initiatives
  • May provide Data Management functional input, considering the impact of the initiative and the impact on Data Management and Parexel as a whole.
  • May support other functions as appropriate to provide meaningful functional feedback on the initiative.
  • Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
What We Are Looking For

We are looking for a professional with a strong background in clinical research and data management, who is able to lead and collaborate with global teams, motivate and guide virtual teams across multiple time zones and cultures to work effectively.

The ideal candidate will have excellent negotiation skills, ability to influence, and good interpersonal, oral and written communication skills, using concise phrasing tailored for the audience with a diplomatic approach.

They will also have a flexible attitude with respect to work assignments and new learning, ability to adjust rapidly to changing environments, and basic presentation skills.

Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust, commitment to first-time quality, including a methodical and accurate approach to work activities, time management and prioritization skills, in order to meet objectives and timelines, evidence of strong problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses, ownership and accountability relative to Key Accountabilities in Job Description, and ability to travel as required.

Written and oral fluency in English is also required.

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