Clinical Operations Excellence Manager

4 weeks ago

Cambridge, Massachusetts, United States Lifelancer Full time
Job Description

At Lifelancer, we're seeking a highly skilled Clinical Operations Excellence Manager to join our team. As a key member of our organization, you will play a crucial role in facilitating optimal clinical development operations, GCP compliance, and trial oversight.

Key Responsibilities:

  • Provide subject matter expertise to support Development Operations with SOP reconciliation, development, and management to ensure accuracy and compliance.
  • Support the development and implementation of process improvement initiatives to ensure efficiency and consistency within the Development Operations and compliance with GCP.
  • Manage oversight activities for cross-program monitoring oversight program.
  • Provide oversight and coordination of applicable governance forums; inclusive of KPI collection and dissemination to appropriate parties.
  • Support compliance activities including SOP activity and training compliance; support teams with risk management/mitigation in accordance with the requirements of ICHE6(R2).
  • Support process-build of clinical development process and business area SOPs as fit for purpose and in compliance with regulatory requirements; confirm SOPs are an accurate representation of the way work is executed.
  • Provide input and support for training sessions on best practices, trends, regulatory requirements guidance, and GCP topics to facilitate continuous improvement in quality and ongoing adherence to standards and regulations.
  • Assist with the creation and delivery of tools, templates, training, and guidance for best practice and reporting and minimizing risk while ensuring quality is integrated into our processes.
  • Drive overall CTMS implementation within Development Operations and be a change agent for the system within Sarepta to ensure adoption of new capabilities and business process.
  • Partner with appropriate functional stakeholders, technology vendors, and CRO partners to avoid and resolve risks within the CTMS.
  • Support an ongoing community of practice and functional superusers for CTMS.
  • Liaise with internal RD Business Operations and RD Quality and Compliance to execute best practice relationship infrastructures, and efficient, high-quality compliant business processes.

Requirements:

  • Experienced in supporting clinical trial GCP compliance/quality management activities.
  • Experience in CTMS systems and supporting implementation and maintenance within the system.
  • Excellent organizational skills with strong attention to detail; proven ability to handle multiple tasks efficiently, effectively, and timely.
  • Ability to work independently and manage deadlines.
  • Excellent interpersonal and communication skills (both written and oral) including ability to develop strong relationships with both internal and external customers in a matrix environment and to timely escalation conflicts for resolution.
  • Problem-solving, process improvement, analytical, and collaborative skills.
  • Self-motivated, calm under pressure and adaptable to a dynamic environment with the ability to support successful change.
  • Experience with corrective/preventive actions and effectiveness checks.
  • Knowledge of Clinical Systems CTMS, TMF, etc.
  • Able to implement directives, meet deliverable timelines, exercise managerial discretion, advanced analytical/forward thinking and prioritization skills, and escalates when necessary.
  • Able to maintain a high level of quality, accuracy, and attention to detail in a fast-paced environment with shifting priorities.
  • Must have strong work ethic, excellent organizational skills, strong oral and written communication skills, have a can-do approach, strong problem-solving skills, and be a team player.
  • Extensive knowledge and application of ALCOA+ standard, Good Clinical Practice, Good Documentation Practices, ICH-GCP guidelines, International Council for Harmonization E6(R2) guidelines and other applicable major Health Authority regulations.
  • Ability to manage and navigate multiple electronic Clinical systems and advanced proficiency in Word, Excel, and PowerPoint.
  • Position may require some travel.
  • BS/BA degree or equivalent required with 5+ years of related experience.
  • 5+ years of experience gained with a CRO, biotech, or pharmaceutical company.

What We Offer:

At Lifelancer, we offer a competitive compensation and benefit package, including a targeted salary range of $112,000 - $140,000 per year. We are an Equal Opportunity/Affirmative Action employer and participate in e-Verify.

Please use the below Lifelancer link for job application and quicker response.

https://lifelancer.com/jobs/view/ef6d5eba298d391482859448fc4cf610

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