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Global Clinical Study Manager

Location:
Cambridge, MA
Company:
IQVIA

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PURPOSE
In this important, high-profile role within IQVIA you will become an integral member of our Project Team. As a Global Study Manager, you will drive the delivery of clinical studies and help bring new therapies to market faster, ultimately improving patients' lives throughout the world.
This role will maximize your strong vendor management skills and your ability to influence and liaise with multiple leaders across IQVIA functions. Candidates with strong budget, time management, and communication skills, as well as those comfortable acting as the accountable point of contact for their customers will succeed in this position. You will be supported by domain experts in every function and enabled by best-in-class technology to ensure the overall project meets delivery requirements.
RESPONSIBILITIES
General GSM Responsibilities
- Oversight of all vendors. Develop scope of work, budgets, and change orders (due to amendments).
- Integral part of study management team (SMT) including Biosafety, Clinical Scientists, Regulatory, Data Management, and GSL (Global Study Lead). Collaborate with other functional groups such as the Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilence, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles.
- Oversee CSMs (Country Study Managers) to ensure protocol/amendments are approved by IRBs, continuous data flow, and escalated issues are communicated to the SMT (Study Management Team).
- Working with Data Management to ensure continuous review of data especially for data locks/snap shots.
- Study start-up work with SMT to decide which countries will be approached.
- Develop a study wide feasibility questionnaire, selecting vendors and evaluating scope of work/budget.
- Closeout- work with CSMs to close sites, work with vendors to transfer data, work on CSR with study team.
- Produce and distribute status, tracking and financial reports for the core project team, other functional groups and senior management.
- Conduct frequent team meetings and ensure regular communication.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Good knowledge of Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics
- Proven ability to understand customer needs and appropriately influence decision making
- Effective mentoring and training skills
- Ability to balance operational and strategic priorities
- Strong communication and interpersonal skills, including good command of English language
- Effective presentation skills
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Demonstrated proficiency at analyzing data and information to make conclusions and drive sound decision making
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in a health care or other scientific discipline with 5 years clinical research/monitoring experience; or equivalent combination of education, training and experience.
PHYSICAL REQUIREMENTS
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers
- Regular sitting for extended periods of time
- Occasional travel requirement
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 jobs.iqvia.com .
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 workday_recruiting@iqvia.com to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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