Director, Clinical Data Team

Meridian Bioscience

  • Québec, QC
  • Permanent
  • Temps-plein
  • Il y a 1 mois
About Meridian:Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets
and distributes a broad range of innovative diagnostic products. We are dedicated to developing and
delivering better solutions that give answers with speed, accuracy and simplicity that are redefining
the possibilities of life from discovery to diagnosis. We are looking for talented and passionate
individuals that help drive our vision. Our innovative culture will allow interested candidates to
discover and create, through collaboration, cutting edge solutions to tough problems. Job Summary:The Director, Clinical Data Team, plays a pivotal role on the Clinical Affairs team by leading the Clinical
Data Management and Biostatistics functions. The successful candidate will be a creative problem
solver and critical thinker with a proven track record in overseeing clinical data teams. He/she must
possess strong communication skills and experience working effectively with cross-functional leaders.
You will provide technical leadership and oversee data management and biostatistics activities at the
program level, ensuring seamless execution from study startup through to regulatory submission.
You must be able to lead in a remote and team environment, is highly organized who can multitask
and adjust direction based on changing project/corporate priorities. This role will be integral in
strategic resource management and advancing Clinical Data Management and Biostatistics process
improvements to foster high-quality data delivery. Key Duties:
  • Oversee and facilitate the personal development of the clinical data team (data managers and
biostatisticians) including fostering career growth, and providing relevant company-specific,
ethical, and regulatory trainings.
  • Responsible for setting the strategic vision for the clinical data team to ensure high quality
data and data analysis to support regulatory submissions.
  • Strategic leadership, organizational, and operational management and guidance to the
personnel and teams within the clinical data team.
  • Lead the data team to ensure project timelines are met, with appropriate quality based on
company priorities.
  • Responsible for technical review of functional deliverables, including clinical study protocols,
statistical analysis plans and reports, final study reports, and publications including abstracts
and posters for the clinical data team.
  • Partner with cross-functional leaders to optimize collaboration, resolve cross-functional
operational challenges, and leverage resources efficiently.
  • Champions the development, maintenance and implementation of processes and tools to
ensure all external data follow data management plans, statistical analysis plans, applicable
standards, study protocols, SOPs and overall clinical objectives.
  • Lead the continued development, review and updating of SOPs and process documentation in
accordance with corporate, industry and regulatory agency standards.
  • Implement the corporate strategic plan within the clinical data team and collaborate with
senior leadership with defining and managing the clinical data team budget, as required.
  • Expertise in working with Electronic Data Capture (EDC) systems and clinical data
management systems like Medrio.
  • Responsible for staffing of the clinical data team for assigned projects.
  • Maintain effective communication, coordination and working relations with other personnel
and management, as well as director board, at the Quebec site.
  • Must be able to concentrate, analyze and solve complex issues throughout the course of the
work shift.
  • Ability to walk up and down several flights of stairs throughout the workday in a multilocation facility.
  • Must be able to adhere to applicable biosafety practices when on the manufacturing floor or
in laboratories.
  • Ability to stand, stoop, reach, push and pull throughout the course of the work shift. Qualifications:
  • Bachelor’s Degree (advanced degree preferred) with 10+ years relevant work experience in clinical data management
  • 10+ years of experience mentoring, managing, and leading a team
  • Working knowledge of US Good Clinical Practices (GCP) is required
  • 10-15 years working in the Medical Device/ Pharmaceutical/Biotechnology/ CRO Industry, IVD experience required.
Preferred Qualifications:
  • Efficient under tight timelines and strict deliverables with demonstrated ability to resolve issues and meet deadlines
  • Strong presentation skills to internal cross-functional teams and external collaborators.
  • May be required to work outside normal working hours to ensure business commitments are met (evenings and
weekends).
  • Show initiative, be detail-oriented, organized, and able to prioritize and balance workload to meet strict and critical deadlines, while being able to work under pressure in a fastpaced environment.
  • Ability to manage, prioritize and report regularly on the progress of multiple projects to executive leadership and crossfunctional teams.
  • Proven knowledge of US regulatory requirements applicable to the conduct of clinical trials.
  • Fluent in French is preferred
*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*

Meridian Bioscience