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, 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.

o   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%