Associate Study Start-Up Manager (Homebased) - IQVIA Biotech

IQVIA Biotech is now hiring for an Associate Study Start - Up Manager for a home-based opportunity.

BASIC FUNCTIONS:

Provides project-related support to the Study Start-Up Manager(s) (SSUM) and other project team members from bid defense through final deliverable for start-up.

May act as Amendment Lead for assigned studies.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Support the preparation of bid defense meeting slides, and in some instances may support the presentation at a bid defense meeting.
• Assist SSUM and start-up team to provide timely and accurate status of project by utilizing IQVIA Biotech systems and reporting tools
• Responsible for assisting to keep all project reporting current, and assuring compliance with system updates; which may include follow-up with project team members to drive completeness of data entry
• Reviewing and identifying project study trends and proactively responding to client and respective team members
• Prepare and QC study start-up reports to assist SSUM with data reporting to internal teams and/or Sponsors.
• Developing appropriate early warning systems of potential obstacles to the successful completion of deliverables; analyzes information and develops innovative solutions to challenges
• Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
• Responsible for assuring projects assigned are run according to SOPs and WP as defined in the scope of work
• Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance
• May act as back-up for SSUM during time out of office
• Supports SSUM with directional insight for Change Orders and Out of Scope work.
• Responsible for supporting SSUMs thorough management of project timelines.  Assist/Manage in the development of project timelines and milestone tracking.
• Responsible for acting as Amendment Lead on assigned studies, overseeing the planning, submissions and approval stage of a substantial amendment
• May assist the study management team with finance forecasts and planning
• Through matrix reporting, responsible for supporting start-up teams both administratively and technically as appropriate.
• Performs other duties as required.

KNOWLEDGE, SKILLS AND ABILITIES:

• Good knowledge of clinical research process
• Excellent organizational and interpersonal skills
• Ability to work independently, prioritize and work within a matrix team environment required.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
• Ability to handle multiple priorities within multiple, complex clinical trials
• Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research
• Extensive working experience with Microsoft Word, Excel, and Power Point
• Strong communication skills (verbal and written) to express complex ideas
• Ability to set baseline targets, track trends and implement mitigation plans

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very limited physical effort required to perform normal job duties.
• Travel may be required, including international travel
• Must be able to secure a credit card cosigned by IQVIA Biotech

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree (or equivalent), preferably in science or related field and 3 - 5 years relevant experience
• Equivalent combination of education, training and experience

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 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.