Trial Study at IQVIA in Durham, NC

๐Ÿ“Œ Durham ๐Ÿท๏ธ Other ๐Ÿ•‘ 2021-05-17
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Senior Virtual Trial Study Lead

JOB OVERVIEWManage the execution of the assigned medium to large multi regionally-based clinical studies per Contract from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with SOPs, policies, and practices.

Responsibilities

Essential Functions
- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensure consistent use of study tools and training materials and compliance with standard processes, policies, and procedures. Implement continuous improvement activities for assigned projects.
- Develop study management plans, together with team assignments and accountabilities and oversight of database maintenance
- Serves as primary project contact with Sponsor to ensure communication is maintained and continuously improved and reporting schedules are adhered to
- Report on team performance against contract, customer expectations, and project baselines to management
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Develop proactive contingency plans to mitigate clinical risk.
- Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and manage study issues and obstacles.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Provide input for the development of proposals for new work and project budgets
- Provide input to line managers of their project team members performance relative to project tasks. Recommend team members further professional development, Support staff development, and mentor less experienced CPMS.
- Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of the CRA team
- Prepare and present project information at internal and external meetings
- Participate in proposal development. May lead bid defense presentations in partnership with Business Development and Senior Clinical Project Management staff
- Define project workload and assignments. Develop and oversee maintenance of internal databases and project plans.
MINIMUM REQUIRED EDUCATION AND EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience.
Typically requires 3 - 5 years of prior relevant experience.Knowledge.
Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education

Bachelor's Degree / Life sciences or related field Additional Work

Experience

7 years clinical research experience including 4 years project management experience Equivalent combination of education, training and experience Skills and Abilities In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines In depth therapeutic and protocol knowledge Strong communication and interpersonal skills, including good command of English language Strong organizational and problem solving skills Demonstrated ability to deliver results to the appropriate quality and timeline metrics Good team leadership skills Effective mentoring and training skills Excellent customer service skills Good judgement Effective presentation skills Ability to manage competing priorities Strong software and computer skills, including MS Office Applications Ability to establish and maintain effective relationships with workers, managers, and clients Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Standard ADA Selection Office Environment.
Physical DemandsSit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects. Use hands and fingers to handle and manipulate objects and/or operate equipment. Travel

Requirements

May require occasional travel. The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time#LI-NM1#LI-RemoteAt 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.

View Application

You will be redirected to IQVIA's preferred application process.

You will be redirected to IQVIA's preferred application process.

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IQVIA ๐Ÿ“Œ Durham, North Carolina ๐Ÿ•‘ 2021-05-17 19:57:16

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