Senior Project Manager, Early Phase

The Senior Project Manager, Early Phase and Translational Research (Sr. PM, EPTR) oversees and manages domestic, regional and/or international projects. The senior project manager is responsible for developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met. The Sr. PM, EPTR is expected to have a working knowledge of drug development and clinical trial execution. S/he has overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The Senior Project Manager acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline).

The Sr. PM, EPTR also acts as a mentor and provides training to other project managers and actively contributes to continuous improvement efforts of the department.

More specifically, the Senior Project Manager, EPTR must:

- Serves as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study.
- Ensures assigned studies are “audit ready” at all times (project team training records, central files, system validation, etc.).
- Communicates effectively with sponsors, study team members, functional departments, and senior management
- Serve as escalation point for project issues to internal and external stakeholders, as appropriate. Proactively identify and resolve conflicts.
- Proactively, manages operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinates tasks and deliverables from all functional departments involved in the project.
- Controls the project budget by ensuring that project team member understand the hours allocation for each task and review time billed to the study against the budget to control write-off and identify out of scope activities for change orders
- Provides efficient updates on trial progress to the internal and external stakeholders, with respect to site selection, vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract
- Defines and manages project resource needs and establish succession plans for key team members.
- Leads study start-up process, including but not limited to conduct of the Trial Kick-off meeting the set-up of trial master file (TMF), site selection and finalization of site lists, site activation, management of vendor set up timelines and site contracting and budgeting.
- Manages risk and control measures to assure project quality. Escalates issue appropriately to Innovaderm management, quality assurance and sponsor, when required.
- Leads client calls, internal work groups, vendor status update meetings. Ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.
- Monitors the quality of study deliverables, (including vendor and SubCRO deliverables), addresses quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the study team
- Analyzes discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed.
- Ensures that project specific training matrix is customized to each study and maintained accurate through out the study
- Ensures all team members including contracted services providers have adequate training on the project by reviewing training records periodically during the trial
- Reviews and approves Innovaderm, site, and vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
- Ensures that study specific documents and project deliverables (e.g., study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) are developed on time and meet study requirements
- Ensures all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
- Provides project status updates to external and internal stakeholders ensuring compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.
- Manages and reports on recruitment status and highlights initiatives needed to mitigate slippage in recruitment ti