IQVIA Associate Director, Clinical Trial Manager, Oncology, IQVIA Biotech in Durham, North Carolina
#IQVIA Biotech opportunity available for a Sr. CTM seeking career advancement to an Associate Director, Clinical Trial Management, Oncology . The ideal candidate will demonstrate expereince as a Senior Clinical Trial be responsible for high level program oversight.
Prefer candidate with previous CRO experience. Previous clinical trial management experience required. Candidates should have experience with global roles and program-level oversight. Early Phase Oncology. (Solid Tumor and Hematology) experience required.
Full job description provided upon request.
The Associate Clinical Monitoring Director is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies, or a program of studies. Associate Clinical Monitoring Directors ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements.
The Associate Clinical Monitoring Director responsibilities are for all activities related to the implementation and execution of clinical studies to include but not limited to the following: client and team related duties; coordinate and oversee daily operations of the clinical monitoring team; and manage project milestones. Additionally, they are responsible for the CRA and regional CTM performance as well as review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
Qualified applicants must meet the following:
KNOWLEDGE, SKILLS & ABILITIES:
Thorough knowledge of clinical research process, including medical and therapeutic areas, phases and medical terminology.
Prior global program/project oversight experience, including basic understanding of EU, UK and NA country regulations.
Prior experience as a Clinical Trial Manager.
Prior experience as a Clinical Research Associate.
Excellent communication skills (verbal and written) with ability to express complex ideas.
Strong presentation skills.
Strong negotiation skills with the ability to communicate difficult concepts clearly.
Excellent organizational skills and proficient at multi-tasking with strong attention to detail.
Strong interpersonal skills, with flexibility to adapt to changing situations.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Prior experience leading, liaising and coordinating cross-functional project teams required.
Ability to lead, motivate and coordinate local and virtual teams.
Ability to manage multiple priorities within various clinical trials.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to delegate, effectively prioritizing own and workload of project team members.
Understanding of basic data processing functions, including electronic data capture; ability to effectively use automated systems and computerized applications.
Possesses cross cultural awareness and is able to adapt appropriately.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Able to mentor CRAs and Clinical Trial Managers.
Able to qualify for a major credit card.
Valid driver’s license; ability to rent automobile.
Willingness and ability to travel domestically and internationally, as required.
MINIMUM RECRUITMENT STANDARDS
BS/BA (or equivalent) in one of the life sciences with a minimum of 6 years direct experience in clinical studies or equivalent level of education and experience.
Minimum of 6 years as a Clinical Monitor/CRA or equivalent industry experience, as well as experience in data handling or analysis.
Minimum of 5 years as a successful Lead CRA or Clinical Trial Manager or equivalent industry experience.
Prior global management/oversight experience required.
Ability to work independently, prioritize and work with a matrix team environment is essential.
Working knowledge of Word and Excel.
Prior experience in electronic data capture (EDC) preferred.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally
Very limited physical effort required to perform normal job duties
CLASSIFICATION: US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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 firstname.lastname@example.org 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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