The Clinical Project Manager fulfills the requirements of managing clinical trials (at the country or regional level, typically) to ensure timely delivery of project required objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Project Manager is responsible for the cross-functional team’s compliance with the project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines and other applicable regulations. The Project Manager is responsible for the overall execution of the project and may be the principal liaison with the client to ensure effective and timely communication of project progress, issues and plans for resolution of those issues.
Job Duties and Responsibilities:
1. Project Guidelines and Communication:
● Develops clear and measurable project management plan in conjunction with the Director, Clinical Operations – Project Management and Sponsor representative(s).
● Management (within the country or regional geography) of clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP.
● Defines timelines, milestones and scope of worklimitations to project staff.
● Establishes project metrics and project report schedules with client representatives. Provides at least monthly project updates.
● May act as the primary liaison between the project team and the sponsor/customers and service providers.
2. Project Analysis and Management
● Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks.
● Manages adherence to project budget and contracts and assists in the identification and development of scope change documents.
● Monitors project status, budget expenditures, and identifies problems and recommends solutions.
● Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
● Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with project team.
● Identifies out of scope work and initiates the scope change process with sponsor representatives.
● Ensures the site contract and budget negotiation process is completed in accordance with project timelines and coast parameters.
● Responsible forreview and approval of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
● Accountable for development, oversight and delivery of project team training.
● Determines needed project processes, trains and maintains project team knowledge/application of project processes.
● Establishes and communicates team performance expectations and guidelines.
● Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility.
● Provides performance evaluation input for Clinipace project team members and service providers.
● Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned.
4. Business Development
● Collaborates with Director, Clinical Operations – Project Management and Directors, Business Development in the development/presentation of Clinipace capabilities/proposal defenses.
● Supports the development of project proposals by participating as requested. Represents Clinipace Project Management at professional, marketing and new business meetings
(Clinical Research Associate)
The Clinical Research Associate (CRA) has the responsibilities for performing the assigned clinical research projects or tasks within their defined territory under the supervision of the (Associate) Clinical Research Manager (CRM)/(Associate) Clinical Research Director (CRD) or equivalence. Responsibilities of CRAⅠinclude performing site selection, initiation, monitoring, closeout of investigational sites, etc.
• Manage the assigned tasks or clinical projects in 100％ compliance with ICH-GCP, relevant SOPs, Local Regulations, other applicable laws and guidelines, and within the agreed timeline, including but not limited to:
Building relationships with investigators and site staff.
Conducting study feasibility survey and site selection.
Preparing required regulatory and IRB/IEC submissions.
Providing training to study staff on conducting the project.
Conducting local investigator meetings, study nurse/CRC training, and site Initiation.
Performing monitoring visits according to the approved Monitoring Plan.
Managing site Investigational Product (IP) supply management.
Conducting source data/document verification (SDV) in compliance with the Monitoring Plan and data review timelines.
Assisting and ensuring site staffs complete CRFs and answer data queries within the timeline defined in the Monitoring Plan.
Completing monitoring visit reports and required follow-up actions.
Ensuring compliance of pharmacovigilance and drug accountability.
Being responsible for the completeness and quality of the on-site files.
Identifying and resolving or escalating any issues to PM or CRM/ (A) CRD in a timely manner.
Closing out study sites on completion of the trial, and ensuring no outstanding open issues.
Maintaining and archiving study documentation and correspondence.
Preparing and attending audit and inspection as needed.
• Contribute to the establishment of a strong team spirit.
• Establish and maintain effective working relationships with other internal departments, including but not limited to: Medical Affairs, Regulatory Affairs, etc.
• Develop working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations