Clinical Research Operations Manager

2 weeks ago

Ridgefield, Connecticut, United States SPECTRAFORCE Full time

Job Title: Clinical Research Operations Manager (REMOTE)

Duration: 12 Months

Pay Rate starts from $65/hr on W2 (Negotiable)

Key Responsibilities:

  • As the Clinical Research Operations Manager, you will be responsible for overseeing the operational aspects of clinical trials.
  • Your role will ensure that recruitment goals, timelines, budgets, and quality standards are met effectively.
  • You will lead the local trial team to maintain the integrity of trial execution, prioritize patient safety, and ensure compliance with regulatory standards.
  • This position requires coordination with the local trial team and collaboration with various functions throughout the planning, execution, and closure of trials.
  • Work within a complex regulatory environment on global clinical trials, collaborating with multidisciplinary teams and various stakeholders, including suppliers and clinical sites.
  • Your performance will directly impact project deliverables, including timelines, costs, and the overall integrity of trial data.
  • Manage multiple assignments simultaneously while balancing competing priorities and contributing to innovative methodologies as a working group member.

Leadership Role:

Lead the local trial team as a Clinical Research Operations Manager.

Trial Management:

In partnership with Site Monitoring Leads and Clinical Research Associates (CRAs), ensure effective trial management.

Act as the primary contact for CRAs, investigators, and site personnel.

Essential Skills:

  • Exceptional communication skills within complex cross-functional environments, ensuring alignment between strategic objectives and actions.
  • Strong project management and stakeholder engagement capabilities, with a solid understanding of the clinical development process and regulatory requirements.
  • Technical Expertise: Comprehensive knowledge of clinical trial operations and execution, with familiarity in relevant therapeutic areas being advantageous.
  • Leadership and Influence: Proficient in navigating complex situations, resolving conflicts, and influencing across organizational levels.
  • Strategic Mindset: Ability to embrace cross-functional initiatives and identify risks while planning effective mitigation strategies.
  • Coordination and Oversight: Skilled in prioritizing tasks, managing activity pace, and optimizing resource utilization.
  • Willingness to travel domestically (10-20% of the time).

Qualifications:

  • Bachelor's degree with a minimum of 6 years of experience in clinical research, preferably within the pharmaceutical sector; or
  • Master's degree or PharmD with at least 4 years of experience in clinical research, preferably within the pharmaceutical sector; or
  • PhD or MD with a minimum of 2 years of experience in clinical research, preferably within the pharmaceutical sector.

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