We are a growing clinical data company based in Chapel Hill, NC that offers its employees an innovative place to work with great benefits. Our employees make a real-world difference and we are looking to find a dynamic Program Lead that is committed to doing good work to join our team.
The Program Lead is responsible for the daily operations of the assigned clinical program and associated deliverables, requiring a thorough understanding of the operational and strategic aspects of the project. Functions as the liaison with internal team members and vendors, as well as outside constituents including an academic steering committee and industry partners.
· Create and implement project plans and guidance documents including clinical monitoring plan, data abstraction guidelines, study reference manual, and training material
· Organize and provide program training for the study team
· 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 and lead the project team
· Manage the generation and delivery of a quarterly status report
· Organize and oversee Steering Committee activities including regular conference calls and two annual live meetings
· Generate and deliver meeting agendas and minutes
· Be a good steward of company finances by reviewing invoices for accuracy and ensuring they are appropriate to pay
· Field and triage client requests
· Be a key player in the publication process
ATTRIBUTES REQUIRED FOR SUCCESS
· Ability to work independently with minimal direction
· High achiever with strong track record of delivering
· Strong sense of initiative; willing to fill gaps as needed
· Strong decision maker and willingness to take accountability
· Ability to problem solve in non-traditional ways
· Open to working in a small company atmosphere and all that entails; dynamic environment, high levels of achievement and a strong culture of teamwork
· Effective communication skills – writing in particular
· Strong Microsoft Excel skills
Education and Experience
Bachelor's degree, preferably in medical or biological sciences or discipline associated with clinical research. 8 years of related pharmaceutical or biopharmaceutical industry experience, with at least 4 of those years in a clinical operations lead or manager role.
- Experience working with Steering Committees or KOLs is a strong plus
- Publication experience
To apply, please send a cover letter and resume to [email protected] and indicate the job title in the Subject line.