Data Management Lead France (Home-based) FSP REGISTER YOUR INTEREST

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

REGISTER YOUR INTEREST

Parexel are currently registering interest for upcoming Data Management Lead roles in France.

In this role the Data Management Lead (DML) 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 Managements 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 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.

These will be fully remote home-based positions.

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.

• Responsible for mapping local study dictionaries to CDISC.

• Contribute technical expertise toward the design implementation and scaling up of

• sensor systems and analytics

• 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 Job Description.

• 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.

• Full understanding or willingness to learn and apply relevant ICH-GCP Guidelines local regulatory requirements and Parexel SOPs and study specific procedures.

• Hands-on experience with Clinical Data Management including Case Report Form (CRF) design CRF annotation database design data collection data-entry data validation discrepancy management medical coding data extraction database locking and regulatory requirements.

• Experience with electronic data captures (EDC) solutions e.g. Encapsia Oracle Clinical Medidata Rave REDCap Medrio.

• Familiarity with medical informatics standards like CDISC.

• Technical experience including Python Unix/Linux environments Version control systems (ex. Git) AWS or other cloud-based development.

Education:

• Masters degree in Health Informatics Computer Science Information Systems or similar field.

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 todays 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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