Jobs at IQVIA

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support project/site start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for new clinical staff including conducting co-monitoring and training visits.
• May provide assistance with design of study tools, documents and processes.
• Convey features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

go to method of application »

Participate in and support RFP process (review RFP documents, pricing, attend bid defense)

Other:

• Independently bring solutions to the CDM team/CDM department
• Lead and/or participate in a focus team or global or local best practice team
• Communicate lessons learned and/or present in CDM workshop(s)
• Participate in the development and implementation of new technology or tool
• Present at professional conferences and/or publish articles in professional journals
• Provide review and input on developing, revising, and maintaining core operating procedures and work instructions
• Perform other duties as directed by the functional manager

Required Knowledge, Skills And Abilities

• Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
• Demonstrated expert data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
• Previous experience of handling customer negotiations
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
• Knowledge of operating procedures and work instructions and the ability to apply them in practice
• Knowledge of Good Clinical Practices and relevant regulatory guidelines
• Excellent communication, interpersonal, customer service, and teamwork skills
• Excellent project management skills
• Excellent organizational and problem-solving skills
• Ability to work independently with available resources, e.g., functional managers, senior DTLs
• Comprehensive understanding of clinical drug development process
• Ability to establish and maintain effective working relationships with coworkers, managers and customers

Minimum Required Education And Experience

• Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 5 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience

Physical Requirements

• Extensive use of telephone and face-to-face communication requiring accurate perception of speech

go to method of application »

Provide experienced, comprehensive and advanced technical expertise as part of a team to develop and maintain clinical systems to meet internal and external clients' needs. Plan and coordinate database design and development for local, regional, or transnational use. Provide leadership to the Clinical Data Programming department in the area of technical expertise. Provide internal consulting services, including specifications, user needs analysis for complex project or client requirements.

Responsibilities

• Serve as Lead Programmer Clinical Data Programming on the corporate team.
• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
• Provide expert technical advice and solutions with internal and external clients.
• Program, test, and document databases in accordance with programming standards and validation procedures.
• Program database manipulations and transfers of data for internal and external clients.
• Provide expert review of database development work with regard to programming standards and validation procedures.
• Serve or lead IQVIA committees and task forces to develop complex, technical solutions for projects or client needs.
• Provide software and programming solutions across projects and/or technologies to meet internal and external needs.
• Mentor other team members and Lead Programmers in training and developing technical and/or database expertise.
• Independently bring project solutions to the CDP teams, Clinical Data Programming department, and internal and external technical teams.
• Collaborate with IT in evaluating and/or developing, and implementing new technologies.
• Provide long term evaluations of clinical systems company-wide.
• Develop, revise, and maintain core operating procedures and working instructions with CDP Management.
• Meet milestones as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.
• Interact with corporate team members to negotiate timelines, responsibilities, and deliverables.

Required Knowledge, Skills And AbilitiesMinimum Required Education And Experience

• Expert knowledge of Oracle and/or SAS
• Solid understanding of clinical drug development process
• Excellent organizational, communication, and technical database skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients
• Bachelor’s degree, or educational equivalence, in computer/life science or related field with 7 years of relevant work experience; or equivalent combination of education, training and experience