Job Description

Parexel are currently recruiting for a Data Management Lead I in South Africa.


In this role, the Data Management Lead l (DML I) provides leadership in all aspects of Data Management. Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management's single point of contact to ensure that the contracted Data Management deliverables are being met - specifically in terms of timeliness, financial management and quality.


The DML I works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Management Lead or Subject Matter Experts. They may work as a co-DML with an experienced DML or work independently on less complex trials.

This will be a fully remote home-based position.

Key Accountabilities:

Cross-functional DM Leadership through Database Set up, Conduct and Study Close-Out

Manage and coordinate the integration and utilization of all ancillary systems as appropriate. Highlight issues/risks to delivery by understanding interdependencies. Support mitigations 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, 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. Identify and request functional staff necessary for the project team. 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.

Training

Deliver Project Specific Training to internal DM team as required.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.

Skills:

Ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively. Negotiation skills and ability to influence, in order to achieve mutually beneficial results. Good 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. A 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 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 . Ability to travel as required. Written and oral fluency in English.

Knowledge and Experience:

Experience in clinical research industry or 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 management of project financials with regards to 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 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/potential prior experience in Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products. Demonstrates technical aptitude.

Education:

Bachelor's degree and/or other medical qualifications or relevant industry experience.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.


We supported the trials of most of today's top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

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