Assist with operational tasks across all study phases, from start-up through
closeout, with a focus on early study planning, site setup, and regulatory
submissions.
Coordinate and maintain effective communication with external CROs, core labs,
and other vendors.
Support the preparation and submission of global clinical study applications
(including IRB/EC submissions, regulatory filings, and study notifications).
Collect and organize documentation from study sites, CROs, and external
partners.
Upload and manage clinical trial documents in the eTMF system or other
relevant repositories.
closeout, with a focus on early study planning, site setup, and regulatory
submissions.
Coordinate and maintain effective communication with external CROs, core labs,
and other vendors.
Support the preparation and submission of global clinical study applications
(including IRB/EC submissions, regulatory filings, and study notifications).
Collect and organize documentation from study sites, CROs, and external
partners.
Upload and manage clinical trial documents in the eTMF system or other
relevant repositories.
Requirements:
Experience from a medical device company an advantage.
Skills Competencies
Strong organizational skills with exceptional attention to detail.
Advanced proficiency in Microsoft Excel, including data analysis, manipulation,
and reporting.
Effective communication and interpersonal skills.
Fluent in English (written and spoken), with strong command of scientific and
clinical terminology.
Proven ability to work collaboratively across teams and manage multiple priorities
in a dynamic environment.
Flexible, proactive, and willing to participate in both high-level strategic tasks and
hands-on operational activities.
Experience from a medical device company an advantage.
Skills Competencies
Strong organizational skills with exceptional attention to detail.
Advanced proficiency in Microsoft Excel, including data analysis, manipulation,
and reporting.
Effective communication and interpersonal skills.
Fluent in English (written and spoken), with strong command of scientific and
clinical terminology.
Proven ability to work collaboratively across teams and manage multiple priorities
in a dynamic environment.
Flexible, proactive, and willing to participate in both high-level strategic tasks and
hands-on operational activities.
This position is open to all candidates.
