Project Specialist

CaidyaChinaonsiteSalary not postedView the original posting at Caidya ↗

Job Description: Job Overview: The Project Specialist will work alongside the Project Manager, or equivalent, in the delivery of the contracted tasks and responsibilities, as outlined in the project’s scope of work and contract. The Project Specialist will ensure the Project Management activities are delivered in a timely and consistent manner. 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. · 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, identifies missing data and determines 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 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, vendor, and site payments, as applicable. Coordination · Supports and coordinates the set up and maintenance of functional plans and project-specific procedures, guidelines, documents, and forms with the project team. · With the PM/PD, develops/distributes time sheet guidelines for Project Teams and supports the project team training in these. · With the PM/PD, 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. Supervisory Responsibilities: No supervisory responsibilities. Job Requirements: Education 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). Experience o 1 year experience in the Clinical Research industry required. Prior relevant work experience in clinical systems (e.g., CTMS, eTMF, ED

Tools named in this posting

veeva vault etmf veeva vault ctms

The people who work here are one introduction away.

We show you who they are and write your first message — the insider list for this posting is filling in now. You have one introduction. The rest follows.

People at Caidya you can reach out to

36 of 55 public LinkedIn profiles found in searches for Caidya list Caidya in their headline — those are the ones you can be confident work there. Pick who to reach out to — we'll draft your message; you make the contact. The rest, when shown, are marked Unverified.

Profiles are public pages as indexed by the search engine — we never log in to LinkedIn or copy private data, and anyone can ask to be removed. Ask to be removed →

Start the conversation More Clinical PM jobs