Shire Jobs

We are seeking candidates with experience working on at least 1 of the following therapeutic areas:

Ophthalmology

Sickle Cell

Dermatology

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.

CLASSIFICATION:

US: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

EU: N/A

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $112,000.00 - $186,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

EEO Minorities/Females/Protected Veterans/Disabled