Manager Clinical Data Management

Employvision Inc.; EUA; Teletrabalho; USD 85 000 - 121 000; Tempo integral

Resumo da oferta

Employvision Inc. is seeking a Senior Data Team Lead (Clinical Data Management) to oversee data management activities from startup through database lock.

This remote US role requires coordinating cross-functional teams, vendors, and global stakeholders while ensuring timely milestones and GCP compliance. The ideal candidate brings hands-on experience with Medidata Rave or Veeva and 3–5 years of leadership in data management or study leadership, managing timelines and deliverables with minimal

Qualificações

• Bachelor's degree in Clinical, Biological, Mathematical Sciences, or a related discipline.
• Candidates without a relevant bachelor's degree must demonstrate significant equivalent experience, approximately 15 years, with a strong supporting career history.
• Minimum 3–5 years of direct experience leading clinical studies or data management programs.
• Hands-on experience with Medidata Rave or Veeva clinical data management platforms.
• Experience with study startup, database migration, and database lock activities.
• Experience with edit check writing and design.
• Strong understanding of data cleaning, query management processes, and clinical data review.
• Knowledge of Good Clinical Practice (GCP) and clinical data reconciliation.
• Demonstrated experience managing cross-functional teams and global stakeholders.
• Excellent communication, leadership, decision-making, and organizational skills.
• Ability to work independently in a remote environment and manage deliverables with minimal supervision.

Responsabilidades

• Lead clinical data management studies from startup through database lock, ensuring milestones and deliverables are completed on schedule.
• Coordinate and oversee internal teams, including clinical programmers, data reviewers, and medical data reviewers.
• Manage study timelines, deliverables, dependencies, and project milestones.
• Lead study startup activities, database migration, database lock, and other critical study phases.
• Oversee edit check writing and design, ensuring appropriate data validation and quality processes.
• Monitor data cleaning activities, review query trends, and address escalations with relevant teams.
• Coordinate vendor reconciliation activities, including SAE reconciliation and external vendor reconciliation.
• Serve as the primary communication liaison between clients, internal teams, and external vendors.
• Lead client and internal team meetings, communicate project status, identify risks, and establish clear action plans.
• Work with global stakeholders across the United States, United Kingdom, South Africa, and India.
• Ensure compliance with Good Clinical Practice (GCP) and clinical data management standards.
• Support study teams in resolving operational challenges and maintaining study timelines.

Conhecimentos

Leadership

Cross-functional collaboration

Study leadership

Remote work

Formação académica

Bachelor's degree in clinical/science or related

15 years equivalent experience if no degree

Ferramentas

Medidata Rave

Veeva

Descrição da oferta de emprego

Job Title: Senior Data Team Lead (Clinical Data Management)

Location: Remote – United States

Pay Rate: $75/Hr. on W2

Duration: 3 Months Contract (Potential extensions up to 9 months)

Work Schedule: Monday–Friday, 40 hours per week

Work Hours: Standard business hours, with occasional flexibility for early or late meetings

Travel: Not Required

Job Summary

Seeking an experienced Senior Data Team Lead to oversee clinical data management activities and lead study execution from startup through database lock. This individual will serve as the primary coordination and communication lead across internal programming teams, data reviewers, medical data reviewers, vendors, and global client stakeholders.

The ideal candidate will have strong clinical data management expertise, hands-on experience with Medidata Rave or Veeva, and at least 3–5 years of direct study leadership experience. The candidate must be capable of independently managing study milestones, deliverables, timelines, and cross-functional activities with minimal supervision.

Key Responsibilities

• Lead clinical data management studies from study startup through database lock, ensuring milestones and deliverables are completed on schedule.
• Coordinate and oversee internal teams, including clinical programmers, data reviewers, and medical data reviewers.
• Manage study timelines, deliverables, dependencies, and project milestones.
• Lead study startup activities, database migration, database lock, and other critical study phases.
• Oversee edit check writing and design, ensuring appropriate data validation and quality processes.
• Monitor data cleaning activities, review query trends, and address escalations with relevant teams.
• Coordinate vendor reconciliation activities, including SAE reconciliation, external vendor reconciliation, and local laboratory data reconciliation.
• Serve as the primary communication liaison between clients, internal teams, and external vendors.
• Lead client and internal team meetings, communicate project status, identify risks, and establish clear action plans.
• Work with global stakeholders across the United States, United Kingdom, South Africa, and India.
• Ensure compliance with Good Clinical Practice (GCP) and clinical data management standards.
• Support study teams in resolving operational challenges and maintaining study timelines.

Required Qualifications

• Bachelor's degree in Clinical, Biological, Mathematical Sciences, or a related discipline.
• Candidates without a relevant bachelor's degree must demonstrate significant equivalent experience, approximately 15 years, with a strong supporting career history.
• Minimum 3–5 years of direct experience leading clinical studies or data management programs.
• Strong experience in clinical data management and study lifecycle management.
• Hands-on experience with Medidata Rave or Veeva clinical data management platforms.
• Experience with study startup, database migration, and database lock activities.
• Experience with edit check writing and design.
• Strong understanding of data cleaning, query management processes, and clinical data review.
• Knowledge of Good Clinical Practice (GCP) and clinical data reconciliation.
• Demonstrated experience managing cross-functional teams and global stakeholders.
• Excellent communication, leadership, decision-making, and organizational skills.
• Ability to work independently in a remote environment and manage deliverables with minimal supervision.

Preferred Qualifications

• Experience with local laboratory data reconciliation.
• Experience with SAE reconciliation and external vendor reconciliation.
• Oncology therapeutic area experience.
• Experience across different clinical study phases, preferably the full study lifecycle, including Phase III.
• Experience with clinical data migration and complex study startup activities.
• Experience working with global clinical research teams.
• Additional mentoring or team training experience.

Technical Skills

• Medidata Rave / Veeva
• Clinical Data Management Systems
• Edit Check Writing and Design
• Clinical Data Review and Cleaning Oversight
• Local Laboratory Reconciliation
• Database Migration and Database Lock
• Microsoft Excel, PowerPoint, Word
• Microsoft Planner or similar project timeline management tools
• This is primarily a study leadership and program management role, not an individual contributor data-cleaning position.
• The candidate will oversee data-cleaning teams rather than personally resolve individual data queries.
• The candidate must have edit check writing experience and a solid understanding of clinical data management processes.
• Typically, one study will be assigned at a time, with a maximum of two studies.
• There are no direct reports; the individual will oversee and coordinate cross-functional teams.
• Financial management, budget management, and statement-of-work management are not major requirements.
• Candidates must be able to work independently and hit the ground running after approximately six weeks of onboarding.