Offer summary

Qualifications:

BS or BA degree required., Minimum 2 years of experience managing Phase II or III studies., Experience in therapeutic areas such as CNS, Oncology, Cardiometabolic, or Rare Disease is beneficial., Strong presentation skills and familiarity with CTMS and other industry-related technology..

Key responsabilities:

Manage overall project deliverables and maintain client relationships.

Collaborate with cross-functional teams and delegate responsibilities.

Ensure study compliance with SOPs and readiness for audits.

Oversee vendor management and budget control for clinical studies.

Job description

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