Fully Remote
Contract Sr. CTM (Lupus)
- Employment Type: Contract or perm
- Required Therapeutic Area: Lupus
- Location: Fully Remote USA
For Contract Roles Only:
- Hours per week: 40
- Contract duration: 6 months
- Potential to convert to perm: Yes
- Travel expectations: none
Job Description:
- Participates in the internal cross-functional study team(s)
- Participate in the selection and management of contract research organizations (CROs) and other outside vendors to support clinical studies
- Manages external vendors, including CROs, central laboratories, and other external service providers, as necessary, from study start-up through final clinical study report
- Assists in the preparation and review of the protocol, informed consent form, case report forms and associated completion guidelines, and other study documents
- Manages study timelines, budgets, and quality metrics in accordance with corporate objectives and goals
- Participates in study feasibility activities
- Oversee study activities such as: selection of investigators, study start-up activities including site initiation and study monitoring activities
- Participate in the preparation and negotiation of clinical site and assigned CRO budgets and track variances
- Project and track study enrollment, deviations, data entry and drug supply
- Adheres to standards and processes in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Develops and maintains relationships with investigators and site personnel to support clinical study activities, including subject recruitment, and ensures protocol and regulatory compliance
- Communicates study trends, issues, mitigation plans, and lessons learned to management
- Manages study-related quality metrics
- Manages multiple initiatives within a small company environment
- Provide routine updates to project team on study status/issues
- Foster positive and constructive relationships with internal and external stakeholders, including client’s team members, CROs, vendors, site staff and patient advocacy groups
- Participate in the development of SOPs and clinical operational systems
- Work with manager to develop and achieve corporate goals within expected timeframe