Clinical Project Manager- TMF Archivist

IQVIA LLC; Durham (NC); On-site; USD 93,000 - 233,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence. The Project Lead drives delivery of clinical studies in Durham, coordinating the core project team, TMF activities and cross-functional collaborations to meet contractual requirements.

Responsibilities include managing study closures, risk, quality, and customer relationships while ensuring financial success and timely milestones across geographies.

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.
• Strong written and verbal communication skills including good command of English and presentation skills.
• Strong problem solving skills.
• Ability to work through others to deliver results, cross-functional partnering, and leadership responsibilities.
• Planning, time management and prioritization skills; ability to organize resources and provide clear direction.

Responsibilities

• 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 contract and strategy and communicate performance.
• Collaborate with other functional groups to support milestone achievement and manage study issues.
• Monitor progress against contract and present project/sub-team information to stakeholders.
• Manage risk and contingencies; lead problem solving and resolution efforts.
• Ensure project quality by identifying quality risks and implementing corrective actions.
• May serve as primary or backup project contact with customer and manage relationships.
• Build the cross-functional project team and oversee collaboration to achieve milestones.
• Ensure financial success of the project and forecast revenue opportunities.
• Identify changes in scope and manage change control processes.
• Identify lessons learned and implement best practices.
• May be assigned as primary contact for vendors and manage vendor relationships as required.
• Adopt corporate initiatives and serve as change advocate.
• Provide input to line managers on performance relative to tasks.
• Support staff development and mentor junior team members.

Skills

Leadership

Communication

Problem solving

Planning

Cross-functional collaboration

Financial stewardship

Vendor management

Project management

Clerical/IT skills

Quality assurance

Education

Bachelor's degree Life sciences or related field

Tools

MS Office (Word, Excel, PowerPoint)

Job description

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 prioritization skills. Ability to organize resources needed to accomplish tasks, set objectives and provide clear direction to others, experience planning activities in advance and taking account of possible changing circumstances.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work. Results-oriented approach to work towards delivery and output.
• Quality - Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving.
• IT skills - Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients. Strong customer service skills.
• Cross-collaboration - Ability to work across geographies displaying high awareness and understanding of cultural differences.
• Finances - Good understanding of project financials including experience managing, contractual obligations and implications.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA competencies (Client Focus, Collaboration, Communication, innovation, Ownership).

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.