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Clinical Operations Manager

Cambridge, MA 02140

Posted: 01/10/2023 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 522577 Is job remote?: No Country: United States

Job Description


The Manager of Clinical Operations works closely with various sponsors, internal team members, study site staff and vendors, to provide management and leadership to plan, prepare and execute multiple complex projects. S/he is responsible for ensuring timely and compliant conduct of clinical trials in accordance with the study protocol, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practices (GCP), other applicable federal and local regulations and guidelines, company goals, and budgets. This position may have line management responsibilities.

RESPONSIBILITIES:

Project-Related Responsibilities 
  • Responsible and accountable for managing one or more clinical trial(s) within the approved budgets and timelines
  • Oversee and manage the operational aspects of clinical trials (e.g., study management, monitoring, site management, project trial master files, enrollment, recruitment, risk management, etc.)
  • Develop the clinical monitoring strategy, including risk-based combination of on-site, remote and centralized monitoring plans, ensuring compliance with Good Clinical Practices (GCP), applicable regulations and accordance with the protocol
  • Prepare and/or review/approve study-related documents (e.g., Clinical Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, ICFs, CTAs/budgets and CRF Completion Guidelines)
  • Set and enforce project timelines with the assigned study team to ensure timely execution of the study, proactively address deficiencies  
  • Manage the feasibility, selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function
  • Define and implement CRA standards, goals and expectations
  • Track compliance of Clinical Operations/CRA Key Performance Indications (KPIs) on a monthly basis
  • Oversee quality and regulatory compliance of clinical monitoring team and investigational sites
  • Assist in development of and management of the study project plan, including timeline, budget, and resources. Assist in the assigning of project resources and hiring process as necessary. Assist project manager in identifying out of scope activities and mitigate as necessary 
  • Participate in protocol, IB, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submission, and other key study documents as appropriate
  • Oversee the clinical implementation of the technical project tools (e.g. CTMS, eTMF, Data Analytics, Site Payments, Medical Imaging, etc.) to ensure fit for purpose design and ICH/GCP/regulatory compliant systems are implemented for the study
  • Ensure CRAs assigned to team receive therapeutic and project-specific training
  • Oversee and track monitoring visit compliance and scheduling. Review and approve trip reports and follow-up letters within required timeframes. Review and approve monitoring travel and expense reports.  Review CRA timesheets. Provide feedback and coach CRAs as necessary
  • Oversee site management activities including but not limited to, site identification, recruitment, selection, training, monitoring, corrective action and preventative action (CAPA) resolutions and investigator site payments
  • Oversee compliance with safety reporting regulations on projects and facilitate communications to ensure compliance as necessary
  • Lead trial quality risk assessments and develop Key Risk Indicators (KRIs), quality tolerance limits (QTLs) and risk responses, for ongoing trial risk management. Develop Integrated Quality Risk Management Plan for the clinical trial and oversee the execution of the plan. Analyze KRIs, escalate findings and execute responses, as necessary. Responsible for the proactive identification of potential study issues/risks and implementation of the mitigations for these risks. Recommend corrective and preventive action plans (CAPAs) as appropriate. 
  • Review and identify trends in enrollment and data entry at sites, and proactively work with clinical monitoring team as well as cross functional teams to identify solutions to issues identified
  • Prepare metrics and updates for Sponsor and management, as assigned 
  • Manage and coach Clinical Trial Associates (CTAs), Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), eTMF Specialists, and other study staff, as needed
  • Organize and manage internal team meetings, investigator meetings, CRA project team meetings and other trial-specific meetings
  • Participate and coordinate SMC and/or DSMB meetings and prepare presentation materials as necessary
  • Act as the key client contact on assigned projects and develop successful working relationships with clients to help secure repeat business
  • Responsible for ensuring the project is “audit ready” at all times (i.e. project team training records, eTMF/central files, system validation documentation, etc.)
  • Responsible for effective communication and high performance of the clinical project team
  • Perform other duties as required

Department Responsibilities
  • Contribute/Author Standard Operating Procedures, manuals, forms and templates to support efficient and compliant best practices of the department 
  • Collaborate and lead the development and improvement of department standard budget and proposal template, client relations materials and/or process development initiatives 
  • Collaborate cross-functionally to create procedures serving the best interest of the entire company
  • Participate and lead business development initiatives, such as proposals, requests for information, bid defenses, capabilities presentations, etc.
  • Take a leadership role in the department continuous improvement initiatives by recommending and implementing innovative process ideas 
  • Lead team trainings and knowledge sharing initiatives 
  • Demonstrate extensive knowledge of and mentor others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies 
  • Manage and/or provide guidance and mentorship to less experienced Clinical Operations team members\  
  • Participate in project and resource assignment decisions, as well as department recruiting and hiring process
  • Support the onboarding and management of new team members, including contract CRAs
  • Support management of the contract CRA pool of resources
  • Continually support organization's core values of top quality and collaborative relationships 
  • Identify ways to provide new learning opportunities to others and support group/individual goal achievement
  • Contribute to the requirement gathering process of the clinical systems supporting the execution of the project (i.e. ePRO, eSource, Medical Imaging, CTMS, eTMF, RTSM, etc.). Assist as needed to the validation execution and validation documentation of the clinical systems. Assist as needed to the development of the site and user training materials to support the use of clinical systems.
  • Provide project management oversight and support as required 
  • Contribute to thought leadership and knowledge sharing activities
  • Participate in qualified vendor selection and provide vendor management/oversight
  • Support the management of the preferred site network
  • Participate in audits as necessary
  • Perform other duties as required

 

EDUCATION:
  • Bachelor’s degree in a scientific or health related field or equivalent; Master’s degree preferred
  • Project Management Professional (PMP) Certification preferred but not required 

 

EXPERIENCE:
  • Minimum of 6 years of Clinical Trial Management or project lead experience at a Clinical Research Organization/Pharmaceutical Company
  • Minimum of 3 years of Project Management experience in a CRO/Pharmaceutical Company, with some managerial experience preferred
  • Other professional and/or educational experience may contribute toward the minimum required, and will be reviewed on an individual basis. 

 

SKILLS: 
  • Working knowledge of the clinical drug development process
  • Strong knowledge and experience of clinical research operations, including interpretation and implementation of International Conference on Harmonisation (ICH) guidelines, Federal Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials and clinical research
  • Understanding of basic data processing functions, including electronic data capture, as well as, experience managing a Clinical Trial Management System (CTMS) and overseeing the proper filing of a study electronic trial master file (eTMF). Medidata systems experience strongly preferred 
  • Strong analytical and problem-solving skills
  • Written, verbal communication and presentation skills in small and large group settings
  • Must possess excellent interpersonal skills
  • Ability to mentor and delegate
  • Ability to effectively multi-task and prioritize
  • Organizational skills and attention to detail 
  • Solid computer skills requirement of Microsoft (MS) applications including (but not limited to) MS Project, Word, Excel, PowerPoint
  • Cross functional and cross-cultural awareness
  • Ability to work in a matrix environment.  Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Ability to deal with time demands, incomplete information or unexpected events 
  • Comfortable using video conferencing solutions and participating in teleconference meetings
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