Opportunity for Clinical Research / Life science Students as Document Management Associate I @ inVentiv Health Clinical
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market.
Job Title: Document Management Associate I
Qualification: B.sc/M.sc Clinical Research / Life Science
Experience: 1-3 years
Job Description:
Process clinical study documentation in accordance with SOP's, GCP and ICH guidelines, may include establishing and maintaining TMF repositories and performing regulatory submissions and document level publishing.
Perform proactive document collection activities, may include tracking of study milestones and liaising with project team to ensure timely document submissions.
Perform Quality control review of clinical and regulatory documents for compliance with Inventiv Health clinical or client specific requirements; provide feedback to document submitters o medical writers as appropriate.
Regulatory submission (IND/CTA,MAA/eCTD)and document level publishing responsibilities may include rendering and addition of document navigation aids as well as compilation and publishing of CSR and its associated appendices per SOP or client requirements and verifying submission readiness of document formatting per ICH competent authority guidelines.
Inventory and archive clinical documents and project related materials ;may include scanning and indexing the documents for electronic (eTMF) studies,shipment of interim or final deliverables to sponsors of offsite storage facilities.
Attend and support file audits and liaise with quality assurance to resolve audit findings as appropriate.
Complete assignments on time and on budget and administrative tasks (eg. status reports) as requested.
Maintain compliance with company requirements. (eg. time tracking, SOP's)
Click here to apply
inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients' therapies to market.
Job Title: Document Management Associate I
Qualification: B.sc/M.sc Clinical Research / Life Science
Experience: 1-3 years
Job Description:
Process clinical study documentation in accordance with SOP's, GCP and ICH guidelines, may include establishing and maintaining TMF repositories and performing regulatory submissions and document level publishing.
Perform proactive document collection activities, may include tracking of study milestones and liaising with project team to ensure timely document submissions.
Perform Quality control review of clinical and regulatory documents for compliance with Inventiv Health clinical or client specific requirements; provide feedback to document submitters o medical writers as appropriate.
Regulatory submission (IND/CTA,MAA/eCTD)and document level publishing responsibilities may include rendering and addition of document navigation aids as well as compilation and publishing of CSR and its associated appendices per SOP or client requirements and verifying submission readiness of document formatting per ICH competent authority guidelines.
Inventory and archive clinical documents and project related materials ;may include scanning and indexing the documents for electronic (eTMF) studies,shipment of interim or final deliverables to sponsors of offsite storage facilities.
Attend and support file audits and liaise with quality assurance to resolve audit findings as appropriate.
Complete assignments on time and on budget and administrative tasks (eg. status reports) as requested.
Maintain compliance with company requirements. (eg. time tracking, SOP's)
Click here to apply
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