Project Specialist II

CaidyaIndia - (home based)remoteSalary not postedView the original posting at Caidya ↗

Job Description: Job Title: Project Specialist II Job Location: India (Remote) Job Overview: The Project Specialist II will work alongside the Project Manager, or equivalent, to provide expertise and coordination to ensure the delivery of the contracted tasks and responsibilities, as outlined in the project’s scope of work and contract. The Project Specialist II will ensure the Project Management activities are delivered in a timely and consistent manner The Project Specialist II may support mentoring and training for other Project Specialists. Job Duties and Responsibilities: Systems/Reporting Owns system access administration (system access, ongoing access surveillance, and access revocation). Supports the PM/PD with set up and maintenance of the MSP study timeline and reporting timelines to the team. Supports the PM/PD with creation of study projections (site feasibility, selection, activation, patient enrolment, etc.), as required. Creates and deploys study specific training matrix and ensures team compliance with assigned trainings, including proper documentation and escalation of non-compliance. 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. Supports PM and works directly with project team in keeping source systems current. Maintains project server and portal where applicable. Meetings Organizes and is actively involved in the Kickoff Meetings for the internal and sponsor study teams, as applicable. Supports with 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/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. Finance Coordinates cross functional financial units and milestones reporting. Maintains out of scope (OOS) tracker. Supports site payments and associated tracking, as needed. May work with Grants Administration to process investigator/site payments and draft amended site budget templates. At study closure, supports the PM/PD in doing final reconciliation of sponsor, vendors, and site payments, as applicable. Coordination Acts as first point of contact for other team members on the project as needed Supports and coordinates the set up and maintenance of functional plans and project-specific procedures, guidelines, documents, and forms with the project team. Develops /distributes time sheet guidelines for Project Teams and supports the project team training in these. Maintains the list of SOPs implemented on the project, if applicable. Sets up and maintains the study working files with the core study specific templates. Supports the project team in managing audits and Corrective Action Plan Agreement (CAPA) resolutions, as applicable. Supports PM/PD with general administrative requests (e.g. formatting support, slide compilation, circulate documents for review etc.) Follow-up, track and transcribe Lab Normal Ranges as outlined in CMG-436-GL. Performs other duties as required by the department or delegated by the PM/PD. 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. End of Study At study closure, supports Medical Writing and PM with collation of Clinical Study Report appendices, where applicable. 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. Supervisory Res

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