Project Manager, US Clinical Operations

Job Description

REMOTE, prefer Atlanta based or EST

Direct Hire, Perm

$140,000-150,000 w/bonus, stock options, 401K

Must be vaccinated for COVID

Must have experience working on inpatient clinical trials, Peds work a plus

Agile Clinical is searching for a Project Manager for a client based in the Atlanta Metro area. The PM will be responsible for implementation and oversight of all areas of clinical trial management within the U.S. This includes, but is not limited to, managing day to day activities of one or more clinical trials beginning with startup and planning of the trial through completion or termination of all closeout activities.

The PM will manage a range of activities for these multicenter studies, including managing vendors such as Contract Research Organizations (CROs) and/or investigative sites. The successful candidate must be extremely self-motivated, proactive, and flexible, as well as being comfortable operating in a small, cohesive matrix environment.

Key Accountabilities:

• Manage the clinical trial process (start-up through closeout) according to industry and corporate standards, with guidance from the Director, Clinical Operations. Expectations include managing vendor performance, internal metrics and communication of study status within the team.
• Ensure that the clinical studies are conducted in accordance with the protocol, U.S. regulations, Good Clinical Practice Guidelines, internal Standard Operating Procedures and applicable Quality Systems requirements
• Ensure the progress and completion of the study in line with Company goals and recommend execution and risk mitigation alternatives, as appropriate, to management
• Drive process for evaluation and selection of CROs and investigational sites Job Description: Project Manager, US Clinical Operations
• Lead internal review process and external communication for clinical site contracts and budgets
• Lead preparation of study specific tools/work with CRO and other vendors to develop appropriate study plans and other documents
• Participate in the set-up and maintenance of study trackers, including timelines and budget trackers, to ensure proper oversight of the study progress, and review results with management
• Review clinical trial related invoices in a timely and accurate manner
• Work with operations to ensure accurate management of all study related supplies
• Assist with writing study documents such as protocol, informed consent, internal Standard Operating Procedures, etc.
• Assist with the coordination and follow-up of all sponsored quality audits, including internal, vendor and investigative sites, as well as any regulatory inspections, as applicable
• Assure the TMF is being set-up, maintained and archived, in accordance with SOPs and ICH-GCP Guidelines
• Oversee, help organize and participate in investigational meetings and site training, as required
• Prepare and present trial specific updates to management and cross functional teams
• Facilitate excellent and appropriate communication within the complete clinical team and executive team

Education and Experience:

• Bachelor’s degree in nursing, medical field or other Life Sciences preferred
• 5+ years minimum pharmaceutical clinical research experience working in various positions in the field of clinical trials, including CRA experience (either CRO and/or sponsor experience are acceptable) with focus on in-patient hospital trials
• Familiarity with respiratory clinical research particularly in neonatology; critical care/NICU experience a plus
• Understanding of the US regulations and guidelines governing clinical trials
• GCP Certification
• Strong critical thinking and problem-solving skills
• Ability to efficiently organize and prioritize work and set deadlines
• Excellent organizational and record keeping skills
• Ability to work independently without oversight, but also work well in a matrixed team environment; maintain a strong working relationship with a diverse range of team members

Work Environment:

• Fast-paced small organization with large collaborating network
• Home office in Atlanta
• Requirement for participation in video conferences and prompt responsiveness to emails and phone calls
• Ability to be productive and successful in an intense work environment is critical
• Flexibility in work hours, when necessary
• Willingness and ability to travel
• Advanced computer literacy

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