The Clinical Project Manager (CPM) plays a key role in managing day-to-day operational and tactical aspects of multiple large-scale clinical projects executed by HistoIndex. These projects often involve samples and data generated from large clinical trials, with varying degrees of customization for data generation and sharing required for different projects. The CPM will also help drive revenue for HistoIndex’s clinical trial services through more upstream pipeline creation and customer engagement. Reporting to the Director of Clinical Development, the CPM collaborates closely to facilitate decisions necessary for timely delivery of high-quality results through successful securing and execution of projects.
Responsibilities:
Project Support for Trials and Studies (Internal):
- Lead planning and communication with cross-functional teams to ensure proper and timely execution of clinical projects.
- Monitor and track compliance to contractual scope of work.
- Implement effective change management strategies when scopes change.
- Communicate relevant project information within the organization.
- Conduct project cost assessments for proposals for new projects.
- Draft proposal documents to share with sponsors including, scope of deliverables and budget.
- Review and implement upgrades to current scope of deliverables and internal communications workflow, to ensure smooth operation as project scales increase.
- Assist in short-term projects related to vendor selection for external tools required for execution of clinical projects.
- Maintain familiarity with MASH clinical trial landscape, including literature search of clinical trial protocols and guidelines.
- Identify new leads in MASH clinical trials or other relevant liver indications.
Sponsor & Client (External Support):
- · Engage customers to present technology solutions related to clinical trials.
- · Address customer inquiries and provide guidance on technology aspects.
- · Lead and manage all aspects of clinical projects, adhering to contracts, protocols and timelines.
- · Act as the primary point of contact for operational issues related to study conduct.
- · Report on project progress and status.
- · Participate in major conferences.
Qualifications:
- · Bachelor’s degree in life sciences or pharmacy.
- · Master’s or advanced degree in relevant disciplines can be considered.
- · Previous experience in clinical project management is preferred.
- · Strong organizational and communication skills.
- · Ability to manage complex projects with attention to detail.
- · Familiarity with regulatory requirements.
- Proficiency in writing and drafting relevant documents for projects.
