Manager, Clinical Operations

General Scope and Summary

Sage Therapeutics is searching for a creative, resourceful, integrative thinker for an important role overseeing interventional clinical trial programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders.  This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). 

Roles and Responsibilities

• Manages all aspects of one or more clinical studies, including the study team and all external vendors; provides oversight and guidance to internal Clinical Operations team.

• Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.

• Create, manage, and execute clinical operations studies, including study management, budget and forecasting timelines as well as Gantt timeline creation.

• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.

• Support the authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary.

• Conduct monitoring oversight visits as needed for the program.

• Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans).

• Partner with CMC/clinical supplies to provide drug supply assumptions.

• Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.

• Study budget management, ensuring actuals are in line with forecast; accountable for invoice approval.

• Drive communication and escalate issues to Clinical Operations Program Lead and, as appropriate, Clinical Sub-Team.

• Manage study resources, internally and externally to optimize performance to study deliverables.  Demonstrate ability to mitigate and escalate changes in scope appropriately.

• Accountable for clinical trial enrollment and risk-mitigations.

• Collaborate with Medical Writing and Medical Science to lead protocol development.

• Lead Study Management Teams in support of clinical trial execution.

• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

• Participation in data cleaning and data trend review as necessary.

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, and good conflict management and negotiation skills. Must have a demonstrated ability to identify and analyze complex issues to develop relevant and realistic plans, programs and recommendations, and the ability to translate strategy into action. Excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks are critical.

Basic Qualifications

• BS/BA degree.

• 4+ years of pharmaceutical or biotechnology industry experience.

Preferred Qualifications

• Master’s degree or above preferred.

• 6+ years of pharmaceutical or biotechnology industry experience.

• Must have through understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.

• Understanding of drug development from pre-IND through NDA.

• Extensive experience managing complex clinical programs, CROs, multiple vendors, budgets, and timelines required.

• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.

• Co-monitoring and monitoring oversight experience required.

• Demonstrated effectiveness in resolving site management issues of varying complexity.

• Protocol, ICF, and CSR writing experience required.

• Strong working knowledge of MS Project and developing Gantt charts is a plus.

• Excellent oral, written, and medical communication skills required.

• Experience