level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment... for internal customers to seek assistance. Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives...
in, and presents at internal, Sponsor, third-party, and investigator meetings Plans for and creates necessary documentation to support... for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management...
attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators. Acts... as first-line subject matter expert for all such CSA elements on assigned studies for internal stakeholders. Advises...
Database data entry Perform quality control of safety cases Generate Investigator Safety Letters SAE reconciliation... as required (i.e., safety management plan, periodic safety reports and presentations) Attending internal and external meetings...
Database data entry Perform quality control of safety cases Generate Investigator Safety Letters SAE reconciliation... as required (i.e., safety management plan, periodic safety reports and presentations) Attending internal and external meetings...
attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators. Acts... as first-line subject matter expert for all such CSA elements on assigned studies for internal stakeholders. Advises...
complex deliverables for internal and external clients with a team of resources, including both full-time employees... delivery, quality standards, and strategic alignment with client objectives. Oversee project teams composed of internal staff...
and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures... as needed. â¢Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper...
validation. Monitor metrics (alert volumes, false positives, investigator throughput, conversion rates) and iterate... ingestion). Create or update product documentation, user guides, runbooks, and support internal teams (sales, services...
, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules..., and internal company standards. Participate in interpreting and planning data presentation for individual study reports...
of all remote and on-site monitoring activities through all study stages. ⢠Routinely reviews the Investigator Site File (ISF... investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines...
of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures... quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal...
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator..., including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe...
with internal and external colleagues to prepare study results for timely publication Attend and contribute to relevant scientific... investigator/site questions about the protocol Respond to site and Health Authority questions about the protocol Conduct periodic...