Senior Project Manager- Study Operations- Patient Centered Solutions

1 miesiąc temu

Warsaw, Polska IQVIA Pełny etat

IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other drug/non-drug interventions. We focus on understanding and meeting the needs of our clients – mostly life science/pharmaceutical companies – through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research.

Role & Responsibilities

• Development of Sponsor Project Plans (SPPs).

• Establish project start-up timelines (including milestones, tasks lists, and dependencies) and track start- up progress through internal meetings and trackers.

• Coordinate the development and communication of technical requirements to facilitate receipt of data transfers from sponsors; execute and test data transfers.

• Identify unique project needs including areas for internal development such as system enhancements. Assist in the related development of the internal tracking databases (see below, ‘support and data management’)

• Daily Clinical Support: Track and manage progress of the clinical review process. Support clinical to develop workflow processes including related training materials.

• Weekly Sponsor Reporting: Act as main point of contact to sponsor. Develop sponsor reports and presentation materials. Set up, organize, and participate in sponsor meetings and correspondence.

• Track and store all study correspondence and materials.

• Support finance in preparation of invoicing materials and reports.

• Assist Clinical team in preparation and review of the final study report.

• Support creation of back-up files and storage of all project data (including: all clinical review systems data and study documentation).

• Support Quality Assurance by developing and documenting internal operations processes and SOP’s and training employees on internal processes.

• Document and train on unique project computer systems; develop internal training materials and conduct internal training.

• Develop and document internal computer system requirements and enhancements.

• Coordinate and develop vendor contracts and statements of work, and facilitate communication between vendors and project teams.

• Test project specific systems and perform user acceptance testing.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Proven problem-solving skills with strong attention to detail.

• A self-starting mind-set with excellent team-based interpersonal skills with the ability to work independently with the full spectrum of our people.

• Strong computer skills, including Microsoft Office applications and SAS.

• Ability to build strong business relationships and influence with key stakeholders at all levels within the business.

• Ability to rapidly assimilate multiple types of information from a variety of sources for effective decision making.

• Excellent written and oral communication skills including grammatical/technical writing skills.

• Excellent attention and accuracy with details.

• Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple tasks and projects.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s degree or equivalent.

• Strong preference of at least five years of work experience in the clinical trial space or at least two years of work experience supporting Rater Training or Rater Surveillance services

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at

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