Project Specialist

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.
• 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, 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.

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

• Experience

• 1 year experience in the Clinical Research industry required.

• Prior relevant work experience in clinical systems (e.g., CTMS, eTMF, EDC) required.

• Skills/Competencies

• Demonstrated ability to conduct activities effectively and efficiently.

• Experience of the clinical research process and terminology Strong written and verbal communication skills, both in English and local language.

• Strong interpersonal skills.

• Team-oriented and a strong team player.

• Working knowledge of ICH/GCP guidelines. Problem-solving skills.

• Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications, with advanced excel skills.

• Able to work in a dynamic, changing environment.

• Demonstrates honesty, trust, fairness, cooperation, self- control, and flexibility.

• Capabilities

• Ability to work remotely.

• Minimal travel may be required 10%