Site Activation Specialist - Reading, United Kingdom - IQVIA

IQVIA

Verified Company

Reading, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Sr Site Activation Specialist - Hybrid - Reading UK

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

May also include maintenance activities.

Essential Functions

Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Inform team members of completion of regulatory and contractual documents for individual sites.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor's Degree Life sciencerelated discipline or professional equivalent Req
5 years' relevant experience including 3 years' Regulatory and Start-Up experience. Equivalent combination of education, training and experience.
Good negotiating and communication skills with ability to challenge
Good interpersonal skills, a strong team player
Good regulatory and/or technical writing skills
Thorough understanding of regulated clinical trial environment and knowledge of drug development process
Proven 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
Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards.
Excellent understanding of study financial management Ability to establish and maintain effective working relationships with coworkers, managers and clients