Clinical Systems Operations Associate

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
We are looking for Clinical Systems Operations Associate II to join our fantastic Clinical Systems Operation team!
The Clinical Systems Operations (CSO) team is primary responsible for building studies in CRG’s Clinical Systems; CTMS, CRG’s eTMF, Activate & Project View.
They follow through its set-up, maintenance, create, and modify study-specific templates to ensure timely site payments, proper subject tracking, and eTMF exports and delivery.

EDUCATION AND EXPERIENCE:

• High / Secondary school diploma or equivalent and relevant formal academic /vocational qualification
• Technical positions may require a certificate
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to work in a team or independently as required
• Strong organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload to meet changing priorities and timelines
• Good English language and grammar skills
• Familiarity with CRG’s business systems, and good computer skills
• Strong judgment, decision making, escalation, and risk management skills
• Self-motivated, positive attitude and good interpersonal skills

SUMMARIZED PURPOSE:

Provides central administrative services to study teams with the creation, activation, maintenance, closure and archival of studies within CRG’s clinical systems.

ESSENTIAL FUNCTIONS

• Performs the tasks necessary to create, activate, maintain, close and archive studies within CRG’s clinical systems.
• Supports study teams with customized template creation including set-up of SVTs (subject visit templates), study access management and study maintenance.
• Coordinates and leads meetings with study teams to finalize study creation, activation, closure and/or archival.
• Ensures any risks, issues or concerns raised by the study team are escalated to a lead team member, line manager and/or are addressed through the appropriate support channels.
• Ensures allocated tasks are performed accurately and consistently, on time, within budget and to a high standard.
• Maintains accurate, consistent and current records within the relevant tracking systems of the tasks performed and any key study-related communications.
• Undertakes projects, assignments, and other administrative tasks per business needs including, but not limited to, data entry and data quality review.