• Charleston, SC, USA
  • Full Time

Job Title: Clinical Operations Project Manager

Reports To: Director, Clinical Operations or Implementation

Within NCGS organizational structure these positions have or may have overlapping responsibilities or collaborative responsibility. The clinical project manager (PM) will function as the primary or co-lead of a study awarded to NCGS. The Project Manager (PM) will oversee and coordinate development of a Project Management Plan (PMP) in agreement with transferred tasks in the MSA, GCP compliance and /or eTMF migration efforts that employ performance metrics, process assessments and process improvements through the life of a trial and / or global quality and compliance effort. The PM may play a significant or lead role in developing budgets, time lines, and quality guidelines for projects, training specifications, thereby ensuring that expectations are met. The project manager guides the selection, delegation of tasks/responsibilities and management of clinical research organization (CRO) clinical operations staff assigned to the project he/she is leading and coordinates the timely and quality delivery of all sponsor delegated tasks. The PM will develop communication algorithms and issue escalation plans, points of intervention, methods of intervention and preventative plans to avoid issues or preventing recurrences.

The PM pro-actively works with members of the project team, identifying issues that might delay the project or threaten the safety of subjects and/or threaten data integrity. The PM makes recommendations to improve project performance. The PM compiles and drives documentation for the project, ensuring the accuracy and quality of clinical, operations and regulatory data.

The PM may assist in developing SOPs, study protocols, and writing clinical study reports or safety reports. The PM is responsible for project staff quality assessment reviews. He/she will develop functional project abstraction tools (monitoring tools) and instructions, conduct training and/or mentoring, and quality review abstracted information from medical records.

The PM has the responsibility to verify that he/she and all team members have protected the rights and well-being of human subjects and that the reported trial data are accurate, complete, and verifiable from source documents. The PM has primary interface responsibilty with the Sponsor organization. Required to travel up to 25%.

Primary Responsibilities

  • Provide leadership in regularly scheduled study team meetings with both internal and external resources;
  • High functioning ability to collaborate with internal and external resources, multi-disciplinary teams, reporting project progress and making recommendations to align with therapeutic and organizational strategies.
  • Provide direction and make critical decisions related to assigned projects.
  • Ensures compliance with applicable regulations ICH/GCP, HIPAA, NIH and other regulatory agencies' requirements and international, national, state and local government regulations; inclusive of Trial Master File (TMF) and electronic TMF mandates, reference models, guidance's, best practices, etc.
  • Budgeting and monitoring of grant and study funds. Intervenes with study staff not adhering to time allocations per tasks
  • Provide review and approval of invoices from study vendors, IRB approvals and informed consent documents, monitoring reports, clinical study agreements, etc.;
  • Provide leadership in the development of study-related documents, including study protocols, informed consent documents, investigator files, DSMB handouts and presentations, etc.
  • Establish close working relationships with physicians, their research staff, outside consultants, vendors and the study sponsor through exceptional communication on a regular basis
  • Coordinate the efforts of the project team, including Clinical Research Associates, Lead, Global Site Development, Contracts Management, etc.;
  • Work closely with the Vice President of Clinical Operations to develop and implement specific study plans and ensure that appropriate resources are available for the project;
  • Responsible for achieving study objectives by working with team members to set project priorities and milestones and resolve project conflicts;
  • Participate in the analysis, summary and reporting of clinical data for regulatory or marketing purposes through the course of the study.
  • Prompt and supportive fielding study staff questions on a day to day basis, recognizing and acting upon trends
  • Communicates well with all study PIs and coordinators and reaches out to them as appropriate
  • Reviews or assigns review to a qualified individual all clinical monitoring reports and correspondence.
  • Develops, implements and evaluates clinical policies, goals and objectives.
  • Willingness to accept responsibilities for special projects as requested.
  • Maintain the elements of the NCGS Quality Management Plan under the PM domain. (See Attachment A and current SOP 600)
  • Perform other duties as assigned by management.
  • This job has supervisory responsibilities.
  • To perform this job successfully, an individual should have good computer skills: good knowledge of Microsoft Office, database software and ability to learn appropriate software and internet-based programs

Knowledge, Skills and Abilities

  • Management skills to organize, evolve and assess processes and teams.
  • In depth knowledge of the product development process from a regulatory and functional standpoint.
  • Skilled in presentation and writing skills as well as, ability to take initiative and think independently are also required.
  • Skilled in the design and implementation of quality assurance systems to assure compliance
  • Skilled in preparing for audits as necessary, supports Corrective Action and Preventive Action (CAPA) initiatives
  • Advanced knowledge of all phases (phase 1, 2 or 3 or post-marketing) of clinical trials through approval. Phase four clinical trials, which encompass ongoing research and development after the product is approved and sold may carry significant label change intentions. This can include discovering other benefits of the investigational product and reporting discoveries to the sponsor organization. The PM is skilled at understanding the depth of oversight required for all phases
  • To perform this job successfully, an individual should have good computer skills: good knowledge of Microsoft Office, database software and ability to learn appropriate software and internet-based programs

Education and Experience

  • Bachelor's (BA / BS) Degree from accredited collegiate institution in the biological sciences or related disciplines in the natural science / healthcare field
  • Eight or more years of experience in clinical research positions, along with management experience.
  • Strong knowledge of clinical operations and the regulatory process is also required.
  • In some cases, specialized medical knowledge might be required, depending upon the projects the manager will be overseeing.
  • Equivalent combination of education, professional training and experience which provides the required knowledge, skills and abilities may be considered.
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