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Senior Clinical Trial Associate
1 month ago
About the Role:
We are seeking a highly skilled Senior Clinical Trial Associate to join our team at Pharmiweb. As a Senior Clinical Trial Associate, you will play a key role in the success of our clinical trials by ensuring the smooth execution of trial activities.
Key Responsibilities:
* Link between CRA and rCTMA in ISF binder preparation and adaptation and assuring availability at the site before SIV.
* Lab ranges, supporting CRA in range collection and uploading.
* CTMS updates (site accounts, site contacts, milestones, site ICFs), supporting CRA and SSUs.
* TMF (document filing, reconciliation and review at site level or country level (for SSU documentation), ISF review and reconciliation eTMF in close-out at site level.
* ICF- customization per site, eTMF upload country and site ICF.
* Help with revision of documents to be submitted (SSU).
* Lab kits (follow arrival).
* Ad hoc printing and shipping documents to sites.
* Organizing meeting and taking minutes, when required.
* Support to dashboard review for quality purposes.
* Support to track specific country logs.
* Support with resolving data queries/site issue.
* Support with payments follow up (sites, stakeholders).
* Tracking of receipt of SUSARs.
* Assistance to completion of Debarment forms.
Requirements:
* A strong experience as a CTA or SMA, this within the pharmaceutical, Biotech or CRO company.
* Experience in QC-TMF, CTMS, eTMF management.
* Strong IT skills.
* Strong communication with the ability to multitask and work effectively under pressure.
* Flexible and proactive mindset.
* Fluency in French and professional proficiency in English.
About Us:
At Pharmiweb, we value diversity, inclusion & belonging. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. Pharmiweb is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
