Full Job Description
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
IQVIA Biotech is now hiring a Study Start-Up Specialist II. Qualified candidates please apply.
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A SSUS II may be assigned to one or more start-up projects, and typically is able to work independently on a project with minimal supervision.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Provides updates during weekly client teleconferences, client meetings, and internal team meetings.
Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
May provide a role in the coordination of the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
May support ISSC Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study.
May distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaire to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.
May review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.
Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process.
Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
Supports sites to answer any questions required for their local IRB/ethics committee submissions.
Serves as IQVIA Biotech liaison with CEC/central IRBs/REBs/ECs, as applicable.
May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
Liaise with legal and internal team to secure authorization of site contracts.
Coordinate document translations required for CEC/EC submissions, as needed.
Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA), CEC and Ethics Committee (EC) submission documentation, and similar information for other related organizations, for the assigned countries.
Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
Notifies the Regulatory Advisor representative (RA-R) when initial essential documents are available for review. Works with RA-R to resolve any concerns.
Contributes to the development of site-specific timelines for SIVs at the beginning of the study; and adheres to study timelines.
Documents/escalates study challenges and communicates updates to Project Manager and SSU Lead/Management.
Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
Update study start-up timeline tool, per IQVIA Biotech SOP.
Participates in reviewing Safety and Regulatory management plans.
Responsible for transitioning sites from SSU to File Maintenance representative.
Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
Participates in financial and/or resource forecasting, as applicable.
Performs other duties as required.
KNOWLEDGE, SKILLS & ABILITIES:
Good knowledge of clinical research process related to study start-up and medical terminology
An understanding of Regulatory and Central/Local ethic submission processes for assigned countries
Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members
Excellent organizational and interpersonal skills
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
Ability to manage multiple competing priorities within various clinical trials
Working knowledge of current ICH GCP guidelines and applicable regulations
Ability to reason independently, assess and recommend specific solutions in clinical settings, and mentor junior SSU staff
Excellent verbal and written communication skills required in local language for assigned countries.
Ability to work independently, prioritize and work with a matrix team environment is essential.
Working knowledge of Word and Excel is required.
Ability to travel periodically if needed
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.
MINIMUM RECRUITMENT STANDARDS:
Bachelor’s degree (or equivalent), preferably in science or related field and 1.5 – 4 years relevant experience
Equivalent combination of education, training and experience
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
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 firstname.lastname@example.org to arrange for such an accommodation.