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Sr. Clinical Trials Associate

  • Anywhere

Company :
Ascendis Pharma

Location :
Redwood City, California

Expiry Date :
Thu, 15 Apr 2021 23:59:59 GMT

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Description :
* Ensure completeness, accuracy and quality of the Trial Master File (TMF) for allocated trial(s) in compliance with SOPs, the protocol and appropriate regulations, including filing documents and performing QC checks as needed
* User administration (internal and external) for clinical IT systems used in allocated trial(s) according to internal procedures
* Support the Clinical Trial Manager and clinical study team with administrative aspects of clinical trial execution
* Support the CTM in operational aspects of clinical trial execution, as delegated
* Mentoring of new CTA colleagues
* Super user/ Subject matter expert for IT systems or processes
* Receive clinical study documents from study team, sites or vendors, review for completion, accuracy and expiration, and submit to the Trial Master File (TMF).
* Support maintenance of the TMF and assist in quality control as appropriate, including review for missing and expiring documents
* Generate, review & approve TMF document workflows
* Establish and maintain tracking tools for assigned trials
* Create, assemble and coordinate shipping of study materials
* May act as a central contact for designated project communications, correspondence and associated documentation
* Maintain a contact list of all trial related personnel (internal and external)
* Create, review, and remove internal and external users in selected trial related systems or collaborate with relevant CROs to ensure user administration is performed according to internal and external requirements
* Participate in team meetings and assist in preparation of agendas, minutes, and tracking of action items
* Assist in the creation of study materials, including but not limited to documents, presentations, and reports
* Perform administrative tasks to support Clinical Operations Department and team members as needed, including routing documents for signatures in Veeva or with DocuSign / Adobe
* Train and support trial team members, sites and vendors in review of clinical trial documents for legibility and accuracy in accordance with SOPs, the protocol and appropriate regulations
* Train and support trial team members in Ascendis eTMF system
* Support and participate with eTMF expertise during audits and inspections
* Support the CTM in vendor oversight
* Find, order, distribute and track distribution of non-IMP related ancillaries and other clinical trial related materials to clinical sites; or coordinate and oversee these activities if outsourced to a vendor
* Assist in the collection of essential documents for regulatory or ethics submission and site activation
* Support preparation and distribution of Newsletters and other trial wide site communication, as agreed with the CTM
* Support CTMs with additional trial specific tasks, as delegated
* Mentoring and training of less experience CTA colleagues in tasks and processes
* Act as super user or SME for systems and processes
Continuously work to improve processes and systems in Ascendis

Requirements

* BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) or relevant industry experience in lieu
* Minimum 3 years of experience within clinical operations or similar field
* Knowledge of clinical trial documentation and regulatory requirements related to trial master files
* Ideally, understanding of one or more adjacent key functions preferred, for example medical, biometrics, regulatory or clinical trial supplies
* Ability to communicate in a respectful way
* Decision making abilities, but knows when to ask for advice
* Structured, organized and a proactive problem-solver, striking the right balance between detail and progress
* Proactively identifies problems and generates possible solutions to present to a tea
* Excellent attention to detail
* Excellent writing and communication skills
* Experience using MS Office Suite (Excel, Word, PowerPoint)
* Experience working in global/virtual teams
* Comfortable presenting ideas to a group
* Oncology experience preferred

Benefits

* Medical insurance
* Vision insurance
* Dental insurance
* 401(k)
* Paid maternity leave
* Paid paternity leave
* Commuter benefits
* Disability insurance