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  • Iqvia
  • United States Of America, Usa
  • Save Job
  • 4 - 7 Years
  • Posted : above 1 month

Job Description:

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

Responsible for the successful planning, implementation and execution of contracted clinical monitoring activities Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial Assures clear client and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by IQVIA Biotech and its clients

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES

Responsible for all activities related to implementation and execution of clinical studies that include

Client Duties/Responsibilities

Work with Project Manager (PM) to define program targets for clinical monitoring staff and assure work is documented within contracted project scope Communicate and document all interactions with client as required by SOP
Serve as client advocate within IQVIA Biotech
Develop and implement Clinical Monitoring Plan

Team Duties/Responsibilities

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including

Coordinate site management activities

Site identification, recruitment, and selection
Regulatory document collection and review
Overall scheduling and management of all site visits
Develop site/monitoring tools and training materials
Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions

Coordinate and oversee daily operations of clinical monitoring team

Set and enforce project timelines with the assigned study team
Coordinate remote review of clinical data within EDC system
Oversee monitoring visit schedule to ensure compliance with frequency set forth in contract
Review and approve trip reports and follow-up letters within required timeframe
Schedule and manage weekly CRA project team meetings
Ensure CRAs assigned to team receive therapeutic and project-specific training
Manage quality and regulatory compliance among clinical monitoring team and investigational sites

Manage project milestones and proactively address deficiencies

Attend and provide information at monthly projections meetings
Attend and provide information at weekly client teleconferences/team meetings
Assist Project Manager in identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization

Manage CRA performance

Define and implement functional standards, goals, and expectations with clinical monitoring team
Serve as CRA mentor and perform accompanied field assessment visits as required
Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA

Documentation Duties/Responsibilities

Assure that the appropriate IQVIA Biotech and/or sponsor SOPs are followed
Ensure all project documentation is appropriately filed per IQVIA Biotech SOPs
Assist PM in preparation of audit responses, as appropriate
Assist PM with preparation of information for inclusion in monthly report to client

Budget/Contract Duties/Responsibilities

Assist PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
Define the scope of work with the client and clinical monitoring team
Assist PM in identifying and generating changes in scope and notify client of potential changes in scope
Review and approve CRA travel expenses and time sheets

KNOWLEDGE, SKILLS & ABILITIES

Thorough knowledge of clinical research process
Prior experience as a Clinical Research Associate
Strong communication skills (verbal and written) to express complex ideas
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 priorities within various clinical trials
Ability to reason independently and recommend specific solutions in clinical settings
Understanding of basic data processing functions, including electronic data capture
Working knowledge of current ICH GCP guidelines and applicable regulations
Able to mentor CRAs and more junior Clinical Trial Managers
Able to qualify for a major credit card
Valid drivers license; ability to rent automobile
Willingness and ability to travel domestically and internationally, as required

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA

Ability to travel domestically and internationally
Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS

BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience
Minimum of 4 years as a Clinical Monitor/CRA, as well as experience in data handling or analysis
Minimum of 2 years as a successful Lead CRA or Clinical Trial Manager
Excellent verbal and written communication skills
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

Join Us

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 IQVIAs Talent Acquisition team at workday_recruitingiqviacom to arrange for such an accommodation

Job ID R1081823

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consulting Services
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
Iqvia

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