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Clinical Project Management Director, TDU

Location: Livingston
Company: IQVIA
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The TDU is a Sponsor dedicated project leadership unit in various Therapeutics Areas (Rare Diseases, Vaccines, Plasma Derived Therapies, CNS, GI, Marketed products) and sits within IQVIA's global Project Leadership organization. As a member of this group, you will be responsible for delivery of global and/or regional studies and / or critical process and vendor management in a variety of indications. Our TDU team is growing quickly, and candidates with experience in the following areas can expect to have a strong impact:
Rare Diseases (Hematology, Von Willebrand's, Allergy/Immunology)
Plasma derived Therapies
GI (Inflammatory Bowl Diseases, Celiac)
CNS (ADHD, Epilepsy, Sleep disorders, Neuropathies)
Gene Therapy
Sub-Family Description
Manages the delivery of clinical research studies from initiation to closeout.
Ensures that quality deliverables are presented on time and within budget; coordinates workstreams and cross-functional project teams while monitoring the use of consistent tools and methodologies; identifies and evaluates potential project risks and develops mitigation plans; and serves as the primary point of contact with the project sponsor.
Clinical Project Management Directors direct and manage the team responsible for clinical delivery of complex; global full service, multi-regional studies and/or programs. Has strategic decision-making responsibility for the project/program. Responsible for direction and management of portfolios and/or accounts from operational perspective ensuring that studies and/or programs are delivered on time and quality resulting in strong financial performance and customer satisfaction and in accordance with SOPs; policies and practices from pre-award to close-out. Focus on leveraging therapeutic expertise and IQVIA's suite of solutions to drive operational excellence and strategic leadership with our customers.
Essential Functions
Contribute to the development of the project delivery strategy for Request for Proposals (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 operationalise the agreed upon approach.
Oversee the development of integrated study management plans with the core project team.
Direct the execution of clinical studies as per the 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.
Recognize systemic issues at program or portfolio level and identify solutions with the project teams, recommend actions to improve efficiencies and oversee the implementation of best practices, address escalation items with the customer.;
Set objectives of the core project team 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.
Responsible for the management and delivery of large and/or complex studies or programs of studies.
May be responsible for portfolio management with one customer or therapeutic area.
Proactively manage strategic risk (positive and negative) and contingencies 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/portfolio contact with customer and own relationship with key customer contact(s), communicate/collaborate with IQVIA business development as necessary.;
Drive consistency of operational delivery across customer's projects/programs/portfolio.
Build the cross-functional project/program/portfolio 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.;
Responsible for ensuring the financial success of project/programs/portfolio.
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.
Requires extensive knowledge of multiple job areas obtained through advanced education and experience.
Viewed as a leading expert within the field by peers.
Requires 12 years of prior relevant experience including minimum 8 years of project management or relevant functional experience.
Equivalent combination of education, training and experience.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.
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