Clinical Project Manager- TMF Archivist

Job Title: Clinical Project Manager- TMF Archivist

Job Location: Durham, North Carolina, United States of America

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:
Job Overview

Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices.
Essential Functions

- Coordinate and oversee TMY study closure and archival actives
• Coordinate and support the TMF compliance team with TMF transfers and migrations.
• Develop integrated study management plans with the core project team.
• Support study teams with Investigator Site File questions
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.;
• Adopt corporate initiatives and changes and serve as a change advocate when necessary.
• Provide input to line managers of their project team members’ performance relative to project tasks.
• Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

Qualifications

- Bachelor's Degree Life sciences or related field Req
• 5 years of prior relevant experience including > 1 years project management experience or equivalent combination of education, training and experience. Req
• Advanced knowledge of job area, and broad knowledge of other related job areas, typically obtained through advanced education combined with experience. Req
• Experience working within the Veeva Vault TMF
• Communication - Strong written and verbal communication skills including good command of English language. Strong presentation skills.
• Problem solving - Strong problem solving skills.
• Leadership - Ability to work through others to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback, experience productively partnering cross functionally and with customers to advance work effectively and efficiently.
• Leadership - Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
• Organization - Planning, time management and prio