General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for
assisting with daily clinical trial execution activities. The candidate will also assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
Roles and Responsibilities
Collect trial information and disseminate it to the internal project teams, the CRO, relevant vendors and consultants.
Coordinate clinical trial correspondence and study and subject newsletters; and ensure that clinical trial documents are prepared and maintained per SOP/GCP requirements.
Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions.
Assemble data and complete routine analyses for a variety of reports. Enter data to records or logs, and establish and maintain files.
Maintain secure study files including eTMF maintenance and oversight; prepare for archiving of study documentation and accompanying checklists. Includes managing system level tasks within eTMF repository platform.
Coordinate and manage version control of clinical documents.
Provide customer service to investigative sites; contact sites regarding study issues. Respond to various inquiries from patients, physicians, telephone callers and visitors by providing information according to guidelines or directing calls to the appropriate person. May be required to act as liaison between investigational sites/vendors and department management.
Assists with Clinical Study Agreements (CSAs); initiate and/or track confidentiality agreements. Assist in the follow-up and expedition of CSAs.
Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals.
Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
Assist in the coordination of clinical supply shipments, including tracking and shipping clinical study drug and supplies (IV lines, large pharmacy equipment)
Review and approve Essential Documentation packages in support of activation of Investigative sites
Provide guidance and training to new administrative staff.
Develop and maintain investigator/site contact database.
Assist Clinical Lead with reference searches in support of protocol development.
Identify and resolve administrative project issues.
Track and ensure site IND safety letter IRB notifications; and assist in the resolution of audit findings.
Participate in pre-study visits, Site Initiation Visits, as appropriate. Coordinate site initiation visit. Assist in study close visits (site preparation and close-out letters).
Assist in implementing the proposed monitoring plan. Co-monitor with Clinical Lead or designee as appropriate.
Assist in the creation and updating of standardized clinical trial tools and processes, SOPs.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
Knowledge of ICH/GCP and regulatory environments including regulatory documentation review and approval
Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.
Experience with eTMF; ability to directly apply essential document knowledge to file documents accordingly based on the TMF reference model
Strong communication and interpersonal/team skills.
Minimal travel required.
Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.
Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
Excitement about the vision and mission of Sage
Number of Openings:
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All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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