Clinical Operations Manager for Pharmaceutical Development

3 days ago

Deerfield Beach, Florida, United States Lifelancer Full time

About the Role:

We are seeking a Clinical Operations Manager to join our team in pharmaceutical development. The successful candidate will be responsible for managing clinical site startup and engagement process excellence, working closely with the Head of Business Process Excellence & Delivery to develop and execute strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE and the Global Development Office (GDO).

Key Responsibilities:

  • Develop and execute CSSE strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE and GDO.
  • Become a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working.
  • Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates.
  • Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans.
  • Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process.

Requirements:

  • Bachelor's Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable.
  • 6 or more years' experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical development practices.
  • 6 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions.
  • Knowledge or FDA and ICH-GCP guidelines for conducting clinical research.
  • Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
  • Experience in managing global teams, change management and coordinating collaboration with cross-functional teams.
  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
  • Strong strategic thinking, planning, execution, and communication skills.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Compensation and Benefits:

The estimated salary range for this position is $133,000 - $209,000 per year, based on location in Massachusetts, USA. U.S.-based employees may also be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.

About Lifelancer:

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains. For more details and to find similar roles, please visit our website.

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