Narrrow River Management, LP
Responsibilities:
- Facilitates and accelerates the development, execution, completion, and reporting of clinical trial(s) to meet or exceed the clinical program goals within budget and on time.
- Understands and uses a risk-based approach, always prioritizing the safety and welfare of human trial participants.
- Manages program timelines. Identifies and provides solutions to clinical trial issues or risks.
- Coordinates and contributes to designing, planning, development, monitoring and reporting of clinical trial(s) in accordance with ICH and relevant regulatory guidelines.
- Manages CROs/ independent contractors.
- Provides oversight of CRO monitoring activities specifically through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and CRAs.
- Primarily responsible for some or all study level deliverables including study plans (monitoring plan, pharmacy manual, template consent, data management plan, statistical analysis plan, safety management plan, etc.).
- Ensures that all external staff assigned to a study are adequately qualified and trained and that the qualifications and training are documented and submitted to the Trial Master File. Conduct and or facilitate training to CRO clinical study teams on protocol specific topics.
- Ensures that the trial master file is prepared, maintained, and catalogued adequately.
- Oversees the management of clinical supplies and clinical supply vendors.
- Manages selection of study vendors for assigned studies. Manages the vendor(s) throughout the life of assigned clinical trial
- Manages or ensures the adequate management of other trial related materials and vendors, e.g. ancillary supplies, central laboratories, central IRB.
- Oversees investigator meetings and other study level meetings. Creates and delivers presentations on study topics as appropriate.
- Compiles and maintains project specific status reports. Communicates project status to clinical team. Alerts team to risks for study subjects, data quality, timelines, budget, and regulatory compliance.
- Leads ongoing review of data to ensure quality and consistency.
- Manages program budget(s) and oversees budget negotiation process.
- Provides input on investigational site selection in collaboration with study team.
- Ensures the management and tracking to timely resolution of deficiencies identified via monitoring, auditing, project calls and updates or other sources.
Qualifications and Skills Required:
- BA/BS, nursing or related field with scientific background.
- 10+ years’ experience in pharmaceutical clinical research and specifically clinical trial management experience.
- Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA) and European regulations.
- Must enjoy working in an environment that requires:
- adeptness in rapid problem assessment
- ability to effectively problem-solve
- ability to manage ambiguity
- ability to produce quality driven results
Job Types: Full-time, Contract
Pay: $100,000.00 – $150,000.00 per year
Benefits:
- Flexible schedule
- Health insurance
Schedule:
- 8 hour shift
Education:
- Bachelor’s (Required)
Language:
- English (Required)
Work Location: Remote
