Manager, Clinical Operations

Altasciences

$80K — $110K *
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • High School diploma or GED with related job experience; college degree preferred.
  • 1+ year of experience in people leadership/management in a clinical setting.
  • Preferred experience in Phase 1 clinical research or Phlebotomy.
  • RN, BSN, or Paramedic certification preferred.
  • Excellent written and verbal communication and organizational skills.

Responsibilities

  • Manage the Clinical Operations team including performance reviews and disciplinary actions.
  • Oversee training and maintain training records for team members.
  • Provide direction and assess learning opportunities for team execution.
  • Ensure compliance with protocol requirements during clinical trial activities.
  • Maintain confidentiality of trial participants and sponsor information.
  • Communicate with management regarding trial progress and departmental objectives.
  • Assist with sponsor visits and regulatory audits, resolving findings promptly.
  • Perform clinical trial activities such as data collection and safety measurements.

Benefits

  • Health/Dental/Vision Insurance Plans
  • 401(k)/RRSP with Employer Match
  • Paid Vacation and Holidays
  • Paid Sick and Bereavement Leave
  • Employee Assistance & Telehealth Programs
  • Flexible teleworking options available
  • Training & Development Programs as incentives
  • Employee Referral Bonus Program
Full Job Description
About The Role
The Manager, Clinical Operations is responsible for the management and coordination of Clinical Operations team members and clinical activities during clinical trial execution. The Manager, Clinical Operations will ensure What You'll Do Here and clinical activities are completed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOP)s.

What You'll Do Here
• Management of the Clinical Operations team, including but not limited to, PTO management, timesheet approval, on-going and yearly performance reviews, employee hiring, disciplinary actions and termination.
• Oversee, manage and/or coordinate the training and training records for the Clinical Operations team.
• Proactively assess learning opportunities for the Clinical Operations team.
• Provide direction to team members during the execution of clinical trial activities.
• Ensure Clinical Operations study and staffing needs meet protocol requirements and are scheduled within study timelines.
• Assure supplementary clinical training is performed to meet protocol requirements, including collaboration with pharmacists and PIs on the creation of dose training material and subsequent training of clinical safety officers and technicians.
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Maintain and advocate a high level of customer service and quality within the department.
• Perform clinical trial activities, including but not limited to, data collection, safety measurements, sample handling and in-house testing.
• Performs protocol reviews.
• Provide a continuous line of communication with management teams on the progression of clinical trials.
• Assist in sponsor visits and regulatory audits and ensure the timely resolution to any related findings.
• Ensure the resolution of data queries in a timely manner and escalate when necessary.
• May review and/or approve in-life audit findings, tracks finding trends and makes appropriate corrective actions measures, when deemed necessary.
• Participate in SOP and protocol reviews and assist in ensuring clinical processes are streamlined.
• Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.
• Hold meetings with clinical members to communicate clinical trial needs and/or departmental objectives.

What You'll Need to Succeed
• High School diploma or GED, related job experience and demonstrated leadership involvement required; college degree and experience in Phase 1 clinical research preferred.
• People leadership/management, preferably 1+ year Phlebotomy experience preferred
• RN/BSN/Paramedic Preferred• Excellent written and verbal communication, leadership, interpersonal and organizational skills.
• Customer service focused, able to work in a fast-paced environment.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:
• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable

Altasciences' Incentive Programs Include:
• Training & Development Programs
• Employee Referral Bonus Program

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