Experienced Clinical Program Manager (Clinical Studies/Real World Data) - Direct Hire/Top $$
Our client, an RTP area firm that offers real world clinical data solutions to improve clinical, medical, and commercial outcomes, is actively recruiting for a highly skilled and versatile Project Manager to lead several key initiatives.
Company is an innovator in its approach to healthcare research, and is growing rapidly. It conducts disease-focused observational research studies using real world data gathered from clinical sites. Projects involve organizing a community of stakeholders (pharma partners, key opinion leaders, regulatory agencies, patient advocacy groups) around a specific disease to generate real world data and insights. Company will pay excellent wage to attract and retain a star to lead these project-based efforts.
Key things to note:
- Projects are high volume clinical studies that involve gathering, synthesizing and analyzing real world clinical data (e.g. medical records) collected on patients with specified disease. Clinical trial management experience will be essential.
- Data from these studies is shared with stakeholders who seek insight and information about patients with the studied disease. Seasoned ability to interpret data/statistics will be important.
- Role will involve driving multiple initiatives, many of which are in the early stages of planning. Right candidate will be an “out of the box’ thinker who works well without a detailed roadmap. Academic research bkgd would be valuable.
- This organization collaborates with many internal and external partners. Right candidate will be extremely effective at overseeing and coordinating the efforts of cross-functional teams.
Responsibilities will include:
- Create and implement project plans and guidance documents including protocol, clinical monitoring plan, data abstraction guidelines, study reference manual, training material
- Oversee all aspects of the clinical operations of the study including site identification, study start up, activation, and enrollment
- Participate in operations activities as needed (e.g. conducting SIVs, performing site management tasks, data monitoring)
- Manage project activities, including frequent follow-ups associated with task owners, many of whom are remote and external partners
- Support integration, coordination and information sharing between ongoing projects
- Identify, escalate and resolve issues, problems and similar situations in a timely fashion
- Maintain discipline on execution of all deliverables and follow-up actions through tracking tools, follow-up meetings and other communication channels
- Develop project tracking and project status reports and graphics using Excel, PowerPoint and similar tools
Targeted candidate will offer a related degree and 4+ years of increasingly responsible roles in Clinical Operations. Broad understanding of drug research and development, with particular strength in onboarding and managing clinical sites, will be important. Other priorities include:
- Proactive, smart and deadline-driven organizational skills
- Acute ability to manage and interpret clinical research data
- Current and continually-advancing technical skills (MS Project; GANTT expertise desired)
- Keen problem-solving, critical thinking and troubleshooting skills
- PMP certification, strongly preferred
Finally, this is a dynamic, empowered, collaborative and mission-driven setting. Seek smart, self-directed and extremely competent professional who can gain the respect and cooperation of colleagues and partners in order to achieve shared success.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration. Local candidates targeted at this time.