||Research Triangle Park, NC
|| Biotechnology and Pharmaceutical, Finance/Economics, Financial Services, Information Technology, Military, Sales, Executive Management, Research & Development
Associate Clinical Project Management Director/Clinical Project Management Director, Project Leadership - Internal Medicine|
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are recruiting for multiple Associate Clinical Project Management Directors/Clinical Project Management Directors across the US specializing in Internal Medicine (Rare Diseases, Immunology, Respiratory and Infectious Diseases & Vaccines) to join our Project Leadership Team. These are home- based opportunities.
Qualifications & Requirements
Clinical Project Management is focused on project productivity, delivery and quality resulting in strong financial performance and customer satisfaction. Focus is on leveraging deep therapeutic expertise and Quintiles’ suite of solutions to drive operational excellence and strategic leadership with our customers. Leadership of the core project team (and/or sub-team) and responsible for achieving large, complex and multi-regional project’s overall objectives to the Sponsor’s satisfaction per Contract while optimizing speed, quality and cost of delivery and in accordance with SOPs, policies and practices.
- Contribute to the development of the project delivery strategy for RFPs.
- Participate in bid defense preparations. Lead bid defense presentations in partnership with Business Development for large, complex, multi-service, multi-region studies or programs. Understand project strategy and translate the agreed upon approach.
- Develops integrated study management plans with the core project team.
- Accountable for the execution of clinical studies per Contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
- 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 information proactively to all stakeholders internally and externally.
- May be responsible for delivery and management of programs of studies.
- Manage strategic 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 members and planning/implementing appropriate corrective and preventative action plans.
- Serve as primary project/program contact with Customer and own relationship with the key customer contact(s); communicate/collaborate with Quintiles’ sales representatives as necessary.
- Drive consistency of operational delivery across customer’s projects/programs.
- Build the cross-functional project/program team and/or sub-team(s) 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.
- Responsible for ensuring the financial success of project.
- Forecast and identify opportunities to accelerate activities to bring revenue forward.
Identify changes in scope and manage change control process as necessary; identify opportunities to increase scope to assist the Customer's business needs.
- Identify and communicate strategic lessons learned and best practices to promote continuous improvement.
- Participate in, champion and adopt function and/or corporate initiatives, changes and/or special project assignments; act as a client liaison, departmental cross-functional liaison and/or change agent.
- Provide input to line managers of their project team members’ performance relative to project tasks. Recommend team members’ further professional development. Support staff development. Mentor less experienced project team members on assigned projects to support their professional development.
Bachelor's degree in life sciences or related field and 10 years clinical research experience including 6 years project management experience; or equivalent combination of education, training and experience.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Broad protocol knowledge; therapeutic knowledge desired
- Strong understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Strong understanding of the competitive environment and how to communicate/demonstrate value through Quintiles solutions
- Strong understanding of other Quintiles functions and their inter-relationship with Project Leadership
- Project management practices and terminology
- Strong understanding of, and experience managing, contractual obligations and implications
- Demonstrated strong understanding of project financials and experience managing project P&L
- Proven ability to work through others in a global environment to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback and coaching; experience productively partnering cross functionally and with customers to advance work effectively and efficiently
- Ability to identify and 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; manages time effectively
- Excellent communication and presentation skills, including good command of English language
- Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results
- Experience working productively in a pressurized environment, managing competing priorities and maintaining a positive outlook at work; handles criticism well and learns from it
- Excellent customer management skills and demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall program
- Open to learning and keeping own knowledge and skill set current and evolving
- Strong software and computer skills, including MS Office applications
- Ability to work strategically to realize project goals, identifying and developing positive and compelling visions for the successful delivery of the project and taking account of a wide range of issues across, and related to, the project
- Demonstrated learning agility and openness to learning and keeping own knowledge and skill set current and evolving
- Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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