About Meridian
Meridian Bioscience is a fully integrated life science company that develops, manufactures, marketsand distributes a broad range of innovative diagnostic products. We are dedicated to developing anddelivering better solutions that give answers with speed, accuracy and simplicity that are redefiningthe possibilities of life from discovery to diagnosis. We are looking for talented and passionateindividuals that help drive our vision. Our innovative culture will allow interested candidates todiscover 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 ClinicalData Management and Biostatistics functions. The successful candidate will be a creative problemsolver and critical thinker with a proven track record in overseeing clinical data teams. He/she mustpossess strong communication skills and experience working effectively with cross-functional leaders.You will provide technical leadership and oversee data management and biostatistics activities at theprogram 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 multitaskand adjust direction based on changing project/corporate priorities. This role will be integral instrategic resource management and advancing Clinical Data Management and Biostatistics processimprovements to foster high-quality data delivery.
Key Duties
- Oversee and facilitate the personal development of the clinical data team (data managers andbiostatisticians) 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 qualitydata and data analysis to support regulatory submissions.• Strategic leadership, organizational, and operational management and guidance to thepersonnel and teams within the clinical data team.• Lead the data team to ensure project timelines are met, with appropriate quality based oncompany priorities.• Responsible for technical review of functional deliverables, including clinical study protocols,statistical analysis plans and reports, final study reports, and publications including abstractsand posters for the clinical data team.• Partner with cross-functional leaders to optimize collaboration, resolve cross-functionaloperational challenges, and leverage resources efficiently.• Champions the development, maintenance and implementation of processes and tools toensure all external data follow data management plans, statistical analysis plans, applicablestandards, study protocols, SOPs and overall clinical objectives.• Lead the continued development, review and updating of SOPs and process documentation inaccordance with corporate, industry and regulatory agency standards.• Implement the corporate strategic plan within the clinical data team and collaborate withsenior leadership with defining and managing the clinical data team budget, as required.• Expertise in working with Electronic Data Capture (EDC) systems and clinical datamanagement systems like Medrio.• Responsible for staffing of the clinical data team for assigned projects.• Maintain effective communication, coordination and working relations with other personneland management, as well as director board, at the Quebec site.
- Must be able to concentrate, analyze and solve complex issues throughout the course of thework 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 orin 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 andweekends).• 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)*
Originally posted on Himalayas
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