Clinical Trial Specialist/Senior Clinical Trial Specialist

Ultragenyx Pharmaceuticals Brisbane , CA 94005

Posted 2 months ago

Why Join Us?

Be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best because we never lose sight of our mission to make a difference in our patients' lives.

Come join our team during this exciting time of growth and opportunities!

The Clinical Trial Specialist/Senior Clinical Trial Specialist (CTS/Sr. CTS) is responsible for providing logistical support for one or more clinical studies. This position will work closely with the Lead Study Manager (LSM) and cross-functional Study Management Team (SMT) to ensure study start-up through closeout activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. The CTS/Sr. CTS works on study activities of diverse scope. The CTS/Sr. CTS supports the LSM in the development and maintenance of study systems, documents and tools; and provides oversight support by tracking and reporting key study metrics. The CTS/Sr. CTS interacts externally with clinical sites and study vendors. The CTS/Sr. CTS may perform select monitoring and oversight visits.

Responsibilities:

  • Performs study feasibility assessments with oversight from the LSM

  • Development of study documents (e.g., Study Management Plan, Clinical Monitoring Plan, Trial Master File Plan, CT.gov postings, etc.), as well as site-facing documents (e.g., Pharmacy Manual, Laboratory Manual, ancillary instructions and tools)

  • May contribute to the development, maintenance and communication of study timelines (e.g., start-up, database lock)

  • May take responsibility for the planning, conduct and follow-up of SMT activities and meetings (e.g., agenda development, minutes, risk mitigation, may lead discussion for selected topics or entire meeting)

  • Manages the collection, review and approval of regulatory documents from clinical sites and ensures ongoing maintenance of records throughout study lifetime

  • Coordinates ICF review and approval process with clinical sites

  • Coordinates investigational product release activities across clinical sites

  • Interacts with study sites regarding general study updates and requests, regulatory document updates and site-specific questions over varying degrees of scope and complexity, as appropriate

  • Coordinates set-up and maintenance of study-specific systems including but not limited to: Trial Master File (eTMF), Clinical Trial Management System (CTMS)

  • Generates, reviews and reports metrics from eTMF, CTMS, EDC and other study-specific systems

  • Tracks clinical data collection against expected (e.g., EDC entry, lab samples, imaging data, etc.)

  • Performs Data Listing Review with oversight from LSM

  • Tracks and reports study metrics for compliance with SOPs and study-level governance documents (e.g. Clinical Monitoring Plan, Protocol Deviation Handling Plan)

  • May manage ancillary vendors (e.g., translation services, patient travel and reimbursement, courier services) and select core study vendors (e.g. specialty and central labs), as defined by the LSM

  • Coordinates Investigator Meetings with oversight from the LSM (e.g., logistics, vendor oversight, site communication, training development and review)

  • Develops training materials and conduct trainings for CRAs, CRO, and study sites

  • Conducts pre-study selection, initiation, interim monitoring/co-monitoring, monitoring oversight and close-out visits, as appropriate

  • May review monitoring visit reports

  • Manages select study monitors, as appropriate

  • Supports eCRF development (e.g., eCRF review, User Acceptance Testing (UAT))

  • Supports system requirements review and UAT for other electronic systems (e.g., IRT/IXRS, eDiary, etc.)

  • Partner with Clinical Procurement & Outsourcing to coordinate vendor contract and change order process, to ensures PO opened depletion of funds against work effort is tracked and accurate

  • Reviews and approves site and select vendor invoices

  • Participates in department initiatives and working groups

  • Provide input/review Standard Operating Procedures

  • Mentors Clinical Trial Associates and junior Clinical Trial Specialists

  • Under the direction of the Lead Study Manager or Clinical Program Manager, the Sr. CTS may also:

  • Manage and oversee multiple core study vendors (e.g., CRO, central lab)

  • Participate or represent Clinical Operations updates during Data Monitoring Committee meetings

  • Participate in vendor selection process

  • Lead feasibility assessments

  • Serve as acting LSM for less complex studies (e.g., lead SMT, represent study on behalf of Clinical Operations)

Requirements:

  • Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)

  • At least 2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor)

  • Fluency in study phases and demonstrable knowledge of how they apply to clinical development

  • Strong working knowledge of ICH Good Clinical Practice guidelines

  • Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management)

  • Able to handle multiple tasks and deadlines

  • Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors

  • Able to identify issues and take appropriate actions

  • Highly effective verbal and written communication skills

  • Must have the ability to build and maintain positive relationships with management and peers

  • Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

  • 10-30% travel may be required

#LI-TK1

Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.


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VIEW JOBS 10/15/2019 12:00:00 AM 2020-01-13T00:00 Why Join Us? Be a hero for our rare disease patients Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies. Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best because we never lose sight of our mission – to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities! Senior Clinical Trial Specialist is responsible for providing logistical support for one or more clinical studies. This position will work closely with the Lead Study Manager (LSM) and cross-functional Study Management Team (SMT) to ensure study start-up through closeout activities are conducted in accordance with Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. Sr. CTS works on study activities of diverse scope. The Sr. CTS supports the LSM in the development and maintenance of study systems, documents and tools; and provides oversight support by tracking and reporting key study metrics. The Sr. CTS interacts externally with clinical sites and study vendors. The Sr. CTS may perform select monitoring and oversight visits. Responsibilities: * Performs study feasibility assessments with oversight from the LSM * Development of study documents (e.g., Study Management Plan, Clinical Monitoring Plan, Trial Master File Plan, CT.gov postings, etc.), as well as site-facing documents (e.g., Pharmacy Manual, Laboratory Manual, ancillary instructions and tools) * May contribute to the development, maintenance and communication of study timelines (e.g., start-up, database lock) * May take responsibility for the planning, conduct and follow-up of SMT activities and meetings (e.g., agenda development, minutes, risk mitigation, may lead discussion for selected topics or entire meeting) * Manages the collection, review and approval of regulatory documents from clinical sites and ensures ongoing maintenance of records throughout study lifetime * Coordinates ICF review and approval process with clinical sites * Coordinates investigational product release activities across clinical sites * Interacts with study sites regarding general study updates and requests, regulatory document updates and site-specific questions over varying degrees of scope and complexity, as appropriate * Coordinates set-up and maintenance of study-specific systems including but not limited to: Trial Master File (eTMF), Clinical Trial Management System (CTMS) * Generates, reviews and reports metrics from eTMF, CTMS, EDC and other study-specific systems * Tracks clinical data collection against expected (e.g., EDC entry, lab samples, imaging data, etc.) * Performs Data Listing Review with oversight from LSM * Tracks and reports study metrics for compliance with SOPs and study-level governance documents (e.g. Clinical Monitoring Plan, Protocol Deviation Handling Plan) * May manage ancillary vendors (e.g., translation services, patient travel and reimbursement, courier services) and select core study vendors (e.g. specialty and central labs), as defined by the LSM * Coordinates Investigator Meetings with oversight from the LSM (e.g., logistics, vendor oversight, site communication, training development and review) * Develops training materials and conduct trainings for CRAs, CRO, and study sites * Conducts pre-study selection, initiation, interim monitoring/co-monitoring, monitoring oversight and close-out visits, as appropriate * May review monitoring visit reports * Manages select study monitors, as appropriate * Supports eCRF development (e.g., eCRF review, User Acceptance Testing (UAT)) * Supports system requirements review and UAT for other electronic systems (e.g., IRT/IXRS, eDiary, etc.) * Partner with Clinical Procurement & Outsourcing to coordinate vendor contract and change order process, to ensures PO opened depletion of funds against work effort is tracked and accurate * Reviews and approves site and select vendor invoices * Participates in department initiatives and working groups * Provide input/review Standard Operating Procedures * Mentors Clinical Trial Associates and junior Clinical Trial Specialists * Under the direction of the Lead Study Manager or Clinical Program Manager, the Sr. CTS may also: * Manage and oversee multiple core study vendors (e.g., CRO, central lab) * Participate or represent Clinical Operations updates during Data Monitoring Committee meetings * Participate in vendor selection process * Lead feasibility assessments * Serve as acting LSM for less complex studies (e.g., lead SMT, represent study on behalf of Clinical Operations) Requirements: * Bachelor degree or equivalent is required (scientific or healthcare discipline preferred) * At least 2 years previous experience in study coordination (e.g., study site) or study management (e.g., CRO or sponsor) * Fluency in study phases and demonstrable knowledge of how they apply to clinical development * Strong working knowledge of ICH Good Clinical Practice guidelines * Working knowledge of project management concepts (e.g., scope, resources, timeline, risk management) * Able to handle multiple tasks and deadlines * Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors * Able to identify issues and take appropriate actions * Highly effective verbal and written communication skills * Must have the ability to build and maintain positive relationships with management and peers * Experience using computer applications including spreadsheets, email, word-processing software and web-based systems * 10-30% travel may be required #LI-TK1 Ultragenyx Pharmaceutical Inc. is an equal opportunity employer. We understand that diversity of thought, culture and background will help us do the best for our patients. We prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com. Ultragenyx Pharmaceuticals Brisbane CA

Clinical Trial Specialist/Senior Clinical Trial Specialist

Ultragenyx Pharmaceuticals