Project Manager (PM)

Position summary: Project Manager (PM) is the project's point person, responsible for training staff and managing the project to ensure that the project is executed according to the objectives defined by Sponsor, on time, within budget and as per quality standard of Ergomed and principles of Good Clinical Practice.

Duties and responsibilities of PM are:

Project-wise:

• Upon request, supporting Business Development group in developing the study proposal as per Client’s Request for Proposal and contributing to the Bid Defence meeting
• Serving as Point of Contact for Sponsor
• Determining resource requirement for the project; securing the resources in partnership with the Resource Manager, Office Director and Functional Head.
• Verifying and ensuring that all assigned project team members (Monitors, Site Managers, CTAs, Lead Site Manager, Data Manager etc.) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
• Organizing and facilitating project meetings throughout the project (study organization, initiation / kick off meeting, investigator meeting, regular project team meetings during project execution, and project close-out meeting) – with project team members, other Ergomed functional groups as needed, vendors and Sponsor, as appropriate

o  Additional Monitors’ Meetings may be arranged per the project plan, or as required. Those meetings should be documented on Training Attendance Log (FRM/PM/010.07)

o  Participants of Investigator Meeting should be provided with Investigator Meeting Attendance Certificate for their records. Additionally, meeting agenda, list of attendees and training materials should be filed both in TMF and ISF (SOP/PM/013)

• Contributing to study documents development as applicable (e.g. protocol, ICF, CRF, CRF completion guidelines, CSR etc.)
• Developing/review and revise project plans (e.g. project management plan, communication plan, recruitment plan, risk management plan, monitoring plan, safety management plan, data management plan, etc.) including specific Key Performance Indicators (KPIs) to ensure consistent and timely execution of the project with quality and within budget
• Developing study ECIS share folder (with support of IT) in order to facilitate sharing of key study documents / guidelines / templates, and reporting / review of study status and KPIs
• Safeguarding quality of study conduct and initiating corrective / preventative measures as needed – e.g. update of study guidance documents, re-training, co-monitoring, etc.
• Vendor selection/ qualification as required per the contract
• Investigator identification and selection per the contract
• Contracting investigational sites (e.g. investigator / team, institution as applicable)
• Supporting Regulatory Affairs group in the regulatory and EC/IRB submission process
• Reviewing and verifying that all required documents are in good order for the first IMP release to the investigational site
• Ensuring the set up and maintenance of the clinical trial master files as per Ergomed SOP/PM/013 and SOP/ADM/004 (or per Sponsor SOPs) and GCP, including TMF QC
• Management of clinical project, including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality, and GCP
• Providing operational (field and in-house) support to clinical study execution, as needed
• Reviewing of Monitors’ reports. If the master files are set up and maintained by the Sponsor, the PM or Ergomed project lead will ensure all original documentation, including visit reports, are forwarded to the Sponsor, according to SOP/PM/013 and SOP/ADM/004
• Periodic review of cumulative listings of study non-compliance issues to assess whether there are any trends at any site or at the study level and determine if any additional corrective / preventative actions should be taken and/or issues communicated to the responsible parties and Sponsor
• Reporting project status to Sponsor, assigned Project Director, and Ergomed Senior/Executive Management as requested
• Responsible for project profitability

o  Preparing study budget forecast

o  Negotiating out-of-scope tasks / units with the Sponsor

o  Regular reporting to finance department / Head of Clinical Operations

o  Review of project grants / expense reports, and financial trackers (invoicing/expenses) in a timely manner

• Managing the preparations for study specific audits, attending in-house project audits, reviewing audit reports, proposing and overseeing completion of Corrective and Preventative Action Plan
• Coordinating the process of study files reconciliation at the end of the trial in preparation for the file transfer to the Sponsor and identifying a sub-set of files to be archived at Ergomed
• Contributing to review of Clinical Study Report, as requested

o  Participating in review cycles to ensure all protocol and GCP deviations were provided to the medical writer

o  Facilitating the provision of documents and data to the medical writer

• In addition to project related tasks, the PM considered as senior project staff, will be involved in development of Company processes and standard operational procedures by supporting the following activities:

Company related:

• Developing, reviewing and revision of Ergomed SOPs within their area of expertise in order to ensure consistency with Good Clinical Practices and other applicable regulatory standards / requirements
• Contributing to Ergomed training programs to enhance knowledge of Good Clinical Practices, related guidance documents, Ergomed SOPs and Working procedures