Clinical Trial Manager
United States of America
11 months ago
1. Interact with staff from study sponsors, investigational sites, vendors, and internal functional areas to ensure the prompt and successful start-up and conclusion of clinical trials. This comprises additional clinical trial management assistance for the functional groups of Clinical Operations, Biometrics, Safety, and Regulatory.
2. Take charge of the site selection and feasibility procedure. assemble the necessary papers to certify the clinical locations. Support reviewing the records to make sure that clinical locations adhere to ICH-GCP and pertinent regional laws.
3. Assist in drafting and submitting regulatory documentation to the appropriate IRBs and ECs.
4. Working with the Clinical Trial Assistant, responsible for setting up and maintaining studies in the Clinical Trial Management System (CTMS) and Trial Master File (TMF) (s).
5. Create, keep up with, and archive files of important records from investigation locations and records for trial master files. These files must be kept in such a way that they are always accessible for audit and finished for archiving.
6. Assist in the evaluation of the documentation of the data given to research participants, including the informed consent forms.
7. Assist in coordinating investigator meetings, off-site client or internal departmental meetings with meeting planners and vendors.
8. Coordinate with multiple clinical trial stakeholders to create reports that track the status, progress, and hazards of the trials at all investigational sites.
9. Participate in the creation of materials that clarify or assist in clinical trial management. These kinds of papers include information gathering tools and study aids or manuals.
10. In charge of shipping and following up on trial materials (site binders, manuals, guides, etc.)
11. Save and catalogue the monitoring staff's visit reports.
12. Assist with the upkeep of study portals, websites, or newsletters with personnel from internally and external vendors.
13. Assist with processing investigator payments, vendor bills, and expense reports.
14. Encourage the study team staff to provide accurate and timely reports of travel expenses.
15. Comply with departmental SOPs and policies and take part in their creation and upkeep.
16. Support task-based activities during RFP and bid cycles, as well as indirect business development initiatives by cultivating client relationships based on trust via performance, dependability, and superior customer service.
17. Create, maintain, and finish training on sponsor SOPs that are relevant to the study or both.
18. Aid websites in their preparation for audits carried out by sponsors or regulatory bodies.
19. Create and implement a professional development plan.
20. As needed, offer assistance in clinical operations, project management, or other functional areas.
1. A bachelor's, master's, or professional degree in an area linked to the life sciences or health.
2. A minimum of three years of experience doing clinical research in a pharmaceutical, biotechnology, CRO, or research institute environment Project management expertise is necessary.
3. Proficient technical writing skills. excellent written and vocal English skills.
4. Complete understanding of medical jargon.
5. Evidence of comprehension of overall clinical trial processes and procedures, clinical site operations, and clinical site monitoring.
6. Awareness of and comprehension of EMA, FDA, and Health Canada rules.
7. Proven leadership skills, including the ability to create goals for people and motivate them to be met while adhering to deadlines, budgets, and resources allotted.
8. Strong interpersonal abilities.
9. Exhibited effective presentation and negotiation skills.
10. Excellent problem-solving skills, especially the capacity to resolve conflicts.
11. Accounting or finance coursework is preferred.
12. The capability to travel, up to 50% of working hours may be necessary.