Responsible for the operational planning and execution of multiple Phase II - III global/international studies, according to ICH-GCP and required regional regulations as applicable from protocol concept through the clinical study report. Ensures completion of study deliverables; develops Therapeutic Areas knowledge and expertise through internal training and external conference attendance. Responsible for the overall management of assigned study conduct, including oversight of the CRO and Trial Project Leaders.
PRIMARY DUTIES AND RESPONSIBILITIES:
1. Manage full scope of study conduct in collaboration with Administrative Operations to ensure studies are conducted according to the Code of federal Regulations, Good Clinical Practices, ICH Guidelines, local regulatory requirements and SOPs.
2. Collaborates with all relevant groups (Trial pharmaceutical partners, Project Arm Leaders, Administrative and Clinical Operations, Cores/Components, CRO, vendors, performance sites) to develop and manage clinical project timelines.
3. Coordinates meetings with study team members as appropriate for the project.
4. Disseminates clinical project communication to all functional groups as appropriate.
5. Contributes to protocol synopsis development and Clinical Operations feasibility assessments.
6. Writing of study protocols, amendments and administrative changes based on approved protocol synopsis, in collaboration with trial pharmaceutical partners, Project Arm Leaders and Clinical Operations.
7. Participation in the selection of CRO and all clinical vendors and cores/components (biomarkers, imaging, data management) for assigned studies.
8. Provides oversight of vendors/subcontracts (biomarkers, imaging, data management) which includes communicating expectations and timelines, ensuring deliverables are on time, with no quality issues.
9. Identify resource issues and escalate to Director, Deputy Director, Clinical Operations Director and/or Administrative Director.
10. Planning and participation in investigator meetings in collaboration with all cross-functional team members.
11. Ensure training of Project Arm Leaders, CRO, vendors, all performance sites and Cores/Components on the protocol and expectations of the study.
12. Responsible for identifying vendor, CRO, performance site, Project Leader, and/or collaborator issues and bringing to the attention of the PI/Director, Deputy Director, Medical Director, Clinical Operations Director and/or Administrative Director for discussion.
13. Provides input to problem-solving and implements corrective action plan when necessary.
14. Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO, where applicable, to resolve performance site issues.
15. Partners with Administrative and Clinical Operations personnel, Project Arm Leaders and CRO and/or vendors (biomarkers, imaging, data management) for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
16. Escalate issues relevant to medical personnel as appropriate for medical monitoring, safety, and exemptions/deviations.
17. Manages timelines and maintain project tracking system with current study status and provide accurate progress reports on assigned studies as requested.
18. Collaborate with pharmaceutical partners to ensure appropriate and timely drug supply for assigned studies.
19. Maintains all documents related to the project and uploads documents to the appropriate location for maintenance and storage.
20. Review and input to Clinical Study Report.
- bachelors degree or RN
- minimum of 5 years' experience in clinical research and program management including leadership
- experience from the pharmaceutical industry or large CRO
- phase III or IV trial experience
MS, PharmD, or PhD preferred - preferably in a scientific discipline.
* Experience in implementation and project management in a clinical setting is desirable.
* CRA experience and practical experience in protocol development (study design) and a good understanding of the operational execution of clinical protocols.
* Good comprehension of drug development and clinical trial methodology.
* Good understanding of GCP/ICH/FDA requirements and an ability to assess compliance to these guidelines.
* Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings etc).
* Must exercise good judgment to maintain confidentiality and ensure integrity of data.
* Must work effectively in a team environment and be flexible to contribute to the needs of the group
* Knowledge and Skills Communication skills- ability to be clear, direct, and tactful when communicating.
* Basic business and medical writing skills required for protocols amendments, study summaries, and progress reports.
* Ability to organize and manage multiple vendors participating in clinical studies.
* Ability to prioritize work effectively to meet timelines.
* Budget Management - ability to develop a study budget to monitor and control expenditures; provides justification/rationale for budget variances.
* Demonstrates basic presentation skills at Investigator or team meetings.
* Analytical skills - ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
* Responsible for resolving issues with study conduct with appropriate staff and CRO for a clinical study.
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