Project Specialist

INC Research Inc Morrisville , NC 27560

Posted 2 months ago


The Project Specialist performs administrative and supportive activities assigned by the Project Lead to ensure the contracted services and expectations are carried out by the project team in accordance with executed contracts and the customers' expectations.


  • Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.

  • Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.

  • Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.

  • Provide administrative support to Project Leads and functional leads.

  • Ensure all study documents are archived based on the appropriate guidelines and policy.

  • Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.


  • Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience

  • Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

  • Strong organizational skills.

  • Ability to manage time and work independently.

  • High proficiency with full MS Office Applications.

  • Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

  • Ability to travel if necessary preferred (approximately 5%)

  • High level of competence in English language


Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Clinical Project Manager Internal Medicine (HomeBased) Iqvia Biotech

Iqvia Holdings Inc

Posted 2 days ago

VIEW JOBS 11/27/2020 12:00:00 AM 2021-02-25T00:00 We're looking for a talented and energetic Sr. Project Manager with strong Internal Medicine experience including Overactive Bladder Disease, Voiding Disorders, and/or Women's Health to join our IQVIA Biotech Internal Medicine Team. At IQVIA Biotech, we're bringing something new to the industry. A flexible model, therapeutically-aligned teams and dedicated resources working in a transparent partnership designed specifically to help small and midsized biotech companies move treatments forward. In this highly specialized and dynamic role, you will utilize your therapeutic knowledge to oversee uniquely-focused clinical studies. Working in a friendly and supportive environment, you will be recognized for your achievements and will have opportunities to contribute to department growth. At IQVIA Biotech we believe our employees are at their best when they bring their whole selves to work. From camaraderie to professional development, working at IQVIA Biotech provides unique opportunities to advance your career alongside a group of diverse, talented colleagues. BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation of clinical studies including: * Manages projects of full scope regional and global projects. Responsible for project team leadership * Responsible for building and maintaining positive client relationships * Ability to negotiate with clients to assure IQVIA Biotech's operational processes are maintained, projects are done within scope * Reviewing and identifying project study trends and proactively responding to client and respective team members * Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; 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 change management on all assigned projects * Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract * Responsible for assuring project timelines are met as per contract * Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead * Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware * In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms. * Provide other project support to Managers, as assigned * Oversee delegation of support staff activities, as necessary * Assists in the development and delivery of capability and proposal defense presentations to prospective clients * Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate. * Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually * Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research. * Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office KNOWLEDGE, SKILLS AND ABILITIES: * Thorough knowledge of clinical research process from Phase I through regulatory submission * Strong communication skills (verbal and written) to express complex ideas * Excellent and demonstrated 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 a variety of complex clinical trials * Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings * Ability to set baseline targets, track trends and implement mitigation plans * Understanding of basic data processing functions, including electronic data capture * Demonstrated problem-solving and financial negotiation skills * Working knowledge of current ICH GCP guidelines CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: * Very limited physical effort required to perform normal job duties. * Up to 20% travel may be required including international travel * Must be able to secure a credit card cosigned by IQVIA Biotech MINIMUM RECRUITMENT STANDARDS: * Previous Management Requirements: Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR Equivalent level of education and experience. Previous experience in managing people within a scientific/clinical environment is required. * Demonstrated Clinical Monitoring and/or Data Management experience required. * Excellent verbal and written communication and presentation skills required. * Demonstrated financial management skills required * Ability to work independently, prioritize and work with in a matrix team environment is essential. * Working knowledge of Word, Excel, and PowerPoint required. * Prior experience in electronic data capture preferred. * Ability to travel domestically or internationally as required. #LI-SA3 #LI-Remote 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 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 to arrange for such an accommodation. Iqvia Holdings Inc Morrisville NC

Project Specialist

INC Research Inc