Nurse Educator - Syracuse, NY - 4714 - Quintiles Transnational - Syracuse, NY

Direct and manage the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities, oversight of the scope of work, budget and resources.

RESPONSIBILITIES

The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending business requirements.

 Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.

 Develop, implement and maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.

 Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.

 Assist with creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.

 Contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

 Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.

 Work with Quality Management to ensure appropriate quality standards for the duration of the project.

 Mentor and coach colleagues as required.

 Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information

 May take a proactive role in developing long standing relationships with preferred Quintiles customers.

 Deliver presentations/training to clients, colleagues and professional bodies, as required.

Qualifications

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES


Good negotiating and communication skills with ability to challenge

Good interpersonal skills, a strong team player

Experience in regulatory and/or technical writing

Good understanding of regulated clinical trial environment and knowledge of drug development process

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

Ability to exercise independent judgment taking calculated risks when making decisions

Good leadership skills, with ability to motivate, coach and mentor

Good organizational and planning skills

Good presentation skills

Good understanding of study financial management

Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor’s degree in life sciences or related field, with 3 years’ relevant experience including demonstrable experience in a regional role or equivalent combination of education, training and experience.

Primary Location

:

Argentina

Other Locations

:

Brazil, Colombia, Mexico

Organization

:

ARG02 – Argentina Clinical Devl Svcs