Peachtree BioResearch Solutions
is a specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a leadership team experienced in buying CRO services on the sponsor side, our operational teams are highly experienced, bring valuable insight, and create trusting partnerships for our sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. We are looking to add a Clinical Project Manager (CPM) who shares our passion for building meaningful sponsor relationships.
The CPM will be responsible for the management of clinical studies and the driver of the client relationship. The CPM will have significant influence on project success and maintain executive level relationship with sponsor clients. Responsibilities:
- Overall responsibility of project deliverables
- Deep understanding of business factors that can influence the trajectory of projects, and provide guidance to internal and external stakeholders as needed
- Collaborate with Clin Ops, BD, and Finance regarding project specifics and delegate responsibilities accordingly
- Create and manage a cross-functional study team and lead study team members
- Ensure adequate participation, contribution and accountability of the clinical study team members in adherence with applicable SOPs and processes
- Ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner
- Vendor oversight including selection, management and quality assurance, especially of monitoring and study management vendors, but also of other area vendors (e.g central laboratories, IVRS, etc), in collaboration with study team members
- Budget management to ensure that the budget appropriately meets the needs of the study, while maintaining cost controls
- Timeline management including the definition, updating and transmittal of the status and planning of the study
- Take on responsibilities as needed across functional areas
Qualifications:
- BS or BA degree
- Minimum 2 years of experience independently managing Phase II or III studies with a sponsor or other CRO
- Therapeutic areas that include CNS, Oncology, Cardiometabolic, or Rare Disease would be beneficial. Willingness to work in those areas is a must.
- Superior presentation skills
- Protocol generation of multiple phase II or III clinical study protocols is preferred.
- Desire to understand the business beyond the project management function - a natural business "curiosity" with a highly positive attitude
- Technology: Expert at traditional Business Software and experienced with CTMS and other industry related technology
- Ability to travel occasionally
In addition to working with great people on high performing teams, full-time employees receive:
- Medical, Dental, Vision, Life, Disability coverage
- 20 days PTO + 13 Paid Holidays
- 401(k)
