American Society of Tropical Medicine and Hygiene (ASTMH)

Clinical Research Project Manager

FHI 360
Durham, North Carolina, United States
9 days ago

Description

Job Summary:

The IDCRC is a NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases. Although the scientific focus will be on malaria/neglected tropical diseases, sexually transmitted infection, respiratory infection and enteric diseases, the Leadership and associated Vaccine Trial Evaluation Units (VTEUs) will work collaboratively to monitor, identify and adjust research priorities based on potential emerging infectious diseases, to include current COVID research. (VTEUs are the companion to the IDCRC LG Award. The VTEUs provide the infrastructure, scientific and administrative expertise to implement the clinical research).
 
FHI 360 has partnered with Emory University to participate in leadership activities and serve as the Protocol Management Center for IDCRC driven research, leading study development and implementation under the direction of the Division of Microbiology and Infectious Diseases (DMID) of the U.S. National Institute of Allergy and Infectious Diseases.

The Clinical Research Program Manager works with all members of the Infectious Disease Clinical Research Consortium (IDCRC), internal and external to FHI 360, collaborating with all partners on the management, development, implementation, conduct and oversight of IDCRC multi-site clinical research studies (from approval of concepts through data analysis and manuscript submission). Works closely with external partners on the creation and maintenance of award level governance.  Closely observes, evaluates and reports on study progress and site operations through study tracking, data management reports, and monitoring follow up. May investigate and develop new methods and processes for project advancement.

Works with major functional area leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations. Collaborates with all IDCRC units on a variety of issues related to project progress and common issues/problems to ensure project progress    and deliverables meet contractual requirements. Ensures that all clinical study management and project deliverables are completed to the Sponsor's satisfaction in accordance with IDCRC governance, Standard Operating Procedures (SOPs), policies and practices.

Accountabilities (Responsibilities):

  • Manages the day-to-day operations of multiple activities spanning the FHI 360 Scope of Work.

  • Develops and implements clinical operational reporting plans, incorporating the study and scientific  plan.

  • Ensures that trial timelines and quality metrics are met.

  • Establishes standardized study milestones and ensures accurate tracking and reporting of study metrics. Serves as primary contact for sponsor and/or functional area representatives in managing protocol reporting.

  • Recommends and implements innovative process ideas to impact clinical trials management and reporting.

  • Provides general oversight of the electronic Trial Master File (eTMF) team for assigned projects to ensure study document compliance for multiple clinical trials

  • Provides general oversight of single IRBs (sIRB) for multi-site trials required to use DMID approved sIRB’s to ensure internal processes are streamlined, compliant and consistent across clinical trials.

  • Identifies risks and resolves issues within the clinical project, ensuring issue escalation; may be responsible for overall project or program risk register development and maintenance

  • Oversees the preparation for and participates in audits by study sponsors or other oversight bodies

  • Establishes and facilitates working groups and committees

  • May author or review departmental/network/company policies and procedures (e.g., SOPs and manuals of operation [MOPs]), abstracts and manuscripts

  • Selects, develops and evaluates personnel to ensure the efficient operation of the team.

Applied Knowledge & Skills:

  • Prior experience and demonstrated success in providing award level project/operational management for clinical studies is required.

  • Ability to prioritize and multitask, proactively follow-up, effectively manage time, and assess, meet and/or adapt to changing priorities and deadlines effectively, with strong attention to detail

  • Able to lead, motivate and coordinate teams

  • Able to work efficiently in a horizontal matrix managing partners and alliances

  • Ability to work independently and in a cross-cultural and geographically diverse team environment

  • Knowledge of the key principles of cross functional project management (Time, Quality, Cost).

  • Comprehensive understanding of ICH Good Clinical Practice (GCP), with knowledge of electronic data capture (EDC), electronic Trial Master File (eTMF), FDA regulations and clinical data management

  • Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides

  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics. Ability to establish and maintain effective working relationships with coworkers, managers, sponsors and collaborators.

  • Effective in presenting information and responding to questions from project teams, external vendors and clients.

  • Prior experience and demonstrated success in working with Principal Investigators (PIs) and research teams required.

  • Ability to establish and maintain systems and processes necessary to control and report trial status and activities.

  • Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.

  • Proficiency in Microsoft Office, and spreadsheets required.

  • Able to delegate, effectively prioritizes own and workload of project team members. Possesses sound interpersonal skills, is flexible and adapts to changing situations. Articulate, professional and able to communicate in a clear, positive concise manner with sponsors and staff.

  • Must be able to read, write and speak fluent English.

Problem Solving & Impact:

  • Works on problems of diverse scope that require analysis or interpretation of identifiable factors.

  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Decisions may affect a work unit or area within a department.

  • Ability to read, interpret and develop clinical protocols and all associated materials. Ability to write clinical reports, protocols, business correspondence, and procedural manuals.

Supervision Given / Received:

  • Receives minimal guidance on new work.

  • Functions independently on projects/assignments.

  • Provides supervisory and mentoring support to other clinical research staff.

  • Provides suggestions on business and operational decisions that affect the department.

  • May serve as team lead to team members.

  • May have direct report/supervision responsibilities.

  • Typically reports to an Associate Director or Director.



Requirements

Education:

  • Master's Degree or its International Equivalent.

  • Health Professions and Related Clinical Sciences.

  • Project Management (PM) Certification preferred.

Experience:

  • Typically requires a minimum of 5 years of experience in clinical research project management, possessing the knowledge, skills, and abilities to perform this job.

Job Information

  • Job ID: 59827382
  • Location:
    Durham, North Carolina, United States
  • Company Name: FHI 360
  • Position Title: Clinical Research Project Manager
  • Job Type: Full-Time
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