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Company | Caidya |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Research Services,Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-08-19 |
Posted at | 10 months ago |
:
- Owns system access administration (system access, ongoing access surveillance, and access revocation).
- Supports the PM/PD with creation of study projections (site feasibility, selection, activation, patient enrolment, etc.), as required.
- Coordinates and provides support with creating the Executive Monthly Report and obtains and maintains study progress reports and trackers.
- Reviews the analytics and reports from Clarity Insight to identify any trends, missing data, and follow-up actions.
- Creates and deploys study specific training matrix and ensures team compliance with assigned trainings, including proper documentation and escalation of non-compliance.
- Maintains project server and portal where applicable.
- Supports PM and works directly with project team in keeping source systems current.
- Supports the PM/PD with set up and maintenance of the MSP study timeline and reporting timelines to the team.
- Support project team and departmental meetings, coordinating the creation of agendas and taking minutes, decision and/or action items, if applicable, for the study sponsor and internal meetings.
- Organizes and is actively involved in the Kickoff Meetings for the internal and sponsor study teams, as applicable.
- Organizes/finalizes meeting materials for presentations (e.g. Investigator meetings, internal and client meetings, departmental meetings, etc.).
- Ensures all outstanding actions as discussed in project meetings, are tracked until completion.
- Coordinates cross functional financial units and milestones reporting.
- At study closure, supports the PM/PD in doing final reconciliation of sponsor, vendors, and site payments, as applicable.
- Supports site payments and associated tracking, as needed. May work with Grants Administration to process investigator/site payments and draft amended site budget templates.
- Maintains out of scope (OOS) tracker.
- Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.
- Supports the project team in managing audits and Corrective Action Plan Agreement (CAPA) resolutions, as applicable.
- Develops /distributes time sheet guidelines for Project Teams and supports the project team training in these.
- Supports and coordinates the set up and maintenance of functional plans and project-specific procedures, guidelines, documents, and forms with the project team.
- Follow-up, track and transcribe Lab Normal Ranges as outlined in CMG-436-GL.
- Maintains the list of SOPs implemented on the project, if applicable.
- Acts as first point of contact for other team members on the project as needed
- Performs other duties as required by the department or delegated by the PM/PD.
- Supports PM/PD with general administrative requests (e.g. formatting support, slide compilation, circulate documents for review etc.)
- Sets up and maintains the study working files with the core study specific templates.
- At study closure, supports the PM/PD in ensuring CTMS system is closed out according to requirements.
- Performs other duties as assigned by Project Management to support department needs. May be required to mentor and oversee other Project Specialists.
- At study closure, supports Medical Writing and PM with collation of Clinical Study Report appendices, where applicable.
- No supervisory responsibilities
- University graduate preferred, healthcare or life science degree a plus.
- Equivalent combination of education and relevant work experience considered (minimum 3 years work experience in absence of a degree).
- Prior relevant work experience in clinical systems (e.g., CTMS, eTMF, EDC) required.
- 3 years’ experience in the Clinical Research industry required.
- Comprehensive knowledge of ICH/GCP guidelines.
- Demonstrates honesty, trust, fairness, cooperation, self- control, and flexibility.
- Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications, with advanced excel skills.
- Demonstrated ability to conduct activities effectively and efficiently.
- Experience of the clinical research process and terminology.
- Demonstrated ability to conduct activities effectively, efficiently and with the minimum of supervision.
- Strong interpersonal skills.
- Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
- Strong written and verbal communication skills, both in English and local language.
- Team-oriented and a strong team player.
- Highly organized.
- Problem-solving skills.
- Able to work in a dynamic, changing environment.
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