Project Manager

JOB SUMMARY

We are seeking a skilled Project Manager to lead and coordinate clinical research projects within our organization. In this role, you will oversee project timelines, manage cross-functional teams, and ensure adherence to regulatory guidelines to deliver high-quality results. The ideal candidate is detail-oriented, proactive, and experienced in the clinical research field.

JOB RESPONSIBILITIES

  • Responsible for leading a team of professionals in completing projects by a set deadline to uphold regulatory requirements for clinical research.

  • Divide up project tasks and setting or adjusting project schedules to adhere to deadlines.

  • Make decisions and monitor the progress of the project to keep it on schedule.

  • Create long and short-term plans, including setting targets for milestones and ensuring deliverables are met.

  • Act as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.

  • Lead project team to ensure quality, timelines, and budget management.

  • Accountable for the financial performance of each project.

  • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.

  • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.

  • Accountable for all project deliverables for each project assigned.

  • Responsible for quality and completeness of TMF for assigned projects.

  • Accountable for maintenance of study information on a variety of databases and systems.

  • Responsible for study management components of inspection readiness for all aspects of the study conduct.

  •  Prepare project management reports for clients and management.

  • Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.

  • Develop strong relationships with current clients to generate new and/or add-on business for the future.

  • Participate in bid defense meetings when presented as potential project manager.

  • Line manage other project management team members and clinical monitoring staff.

  • Oversight for development and implementation of project plans.

  • Plan, coordinate and present at internal and external meetings.

  • Manages resources and timelines associated with all study start-up and implementation activities, including CRO/investigator agreements, and contractual agreements.

  • Leads the development of study specific protocols, consent forms, and other trial related materials as required.

  • Ensures the appropriate development of study documents including, but not limited to, study plans, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.

  • Ensures that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).

QUALIFICATION REQUIREMENTS

  • Bachelor’s degree in a scientific or health-related field, with a minimum of 3-5 years of project management experience in clinical research, preferably within a CRO or pharmaceutical environment.

  • Strong knowledge of Good Clinical Practice (GCP) guidelines and FDA regulations is essential.

  • The candidate must demonstrate exceptional organizational, communication, and leadership skills, with the ability to manage multiple projects and teams effectively.

  • Proficiency in project management software and experience with budget tracking, timeline management, and client communications are highly desirable.

  • Background in ophthalmology, with specific experience in retina-focused clinical trials is a plus.

  • PMP certification or equivalent project management training is a plus.

  • In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

Knowledge, Skills and Abilities:

  • Strong organizational and time management skills, with the ability to oversee multiple projects simultaneously.

  • Effective communication and interpersonal skills to collaborate with cross-functional teams, sponsors, and regulatory agencies.

  • Advanced problem-solving skills to anticipate challenges and develop proactive solutions.

  • Proficiency in project management software and reporting tools.

  • Ability to lead project teams with clarity and purpose, fostering a collaborative and results-oriented environment.

  • Capacity to make data-driven decisions and adjust project plans as necessary to meet timelines and budgets.

  • Adaptability to handle shifting priorities and evolving project needs in a fast-paced research environment.

  • High attention to detail to ensure compliance with study protocols and regulatory standards.

  • Strong oral and written communication skills, with the ability to effectively engage with medical personnel and cross-functional teams.

  • High level of customer focus and responsiveness.

  • Proven adaptability and flexibility in a dynamic work environment.

  • Ability to work independently

  • Proficient computer skills, with strong knowledge of Microsoft Office and the ability to quickly learn new software.