Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
This role is responsible for comprehensive trial and site administration. Under the oversight of the Senior Clinical Operations Manager (COM) or COMs, the person prepares, collates, distributes, and archives clinical documents.
The Clinical Trial Coordinator (CTC) supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to the Internal Review Board / Ethics Review Committee and Health Authorities. The role will collaborate at the local level closely with Clinical Operations Manager (COM), Clinical Research Manage (CRM) and Clinical Research Associate (CRA).
Responsibilities include, but are not limited to:
Trial and site administration:
Track (e.g. essential documents) and report (e.g. Safety Reports)
Ensure collation and distribution of study tools and documents
Update clinical trial databases (CTMS) and trackers
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage Labeling requirements and coordinate/sign translation change request
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.g. electronic Trial Master File (eTMF).
Assist with eTMF reconciliation Execute eTMF Quality Control Plan.
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up, and submissions
Obtain, track and update study insurance certificates
Support preparation of submission package for
Institutional Review Board (IRB/ERC) and support regulatory agencies submissions.
Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Authority (RA) were required per local legislation.
CORE Competency Expectations:
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands-on knowledge of Good Documentation Practices
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
International Council for Harmonisation Good Clinical Practice (ICH-GCP) knowledge appropriate to role.
Excellent negotiation skills for CTCs in finance area.
Behavioral Competency Expectations:
Effective time management, organizational and interpersonal skills, conflict management.
Effective communication with external customers (e.g. sites and investigators).
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus, both internally and externally.
Able to work independently and proactive attitude to solving problems / proposing solutions.
Minimum Required Education and Experience:
B.A./B.S. (Life Sciences/STEM preferred) graduating by June.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Internal Number: R110339
To make a difference in the lives of people globally through our innovative medicines, vaccines, and animal health products. We are committed to being the premier, research-intensive biopharmaceutical company and are dedicated to providing leading innovations and solutions for today and the future.