Manager Study Management – Biosimilars

Target PR Range:56-66/hr
* Depending on experience

• Primary point of contact to lead, manage and coordinate, in partnership with the Contract Research Organization (CRO), the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP
• Oversee the quality and scientific integrity of clinical operations for studies at a global level
• Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables

• Global biosimilar development operational execution through oversight of cross functional trial activities in partnership with CRO
• Ensuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH/GCP guidelines
• Execution of clinical studies with high-quality, on time, and within budget
• Contribute to the authoring and review of key study documents
• Day to day management of study execution including management of study timelines
• Managing program-level operational issues and oversight of study team issue escalation
• Supports / Leads the Global Clinical Study Team for the allocated program(s)
• Communicating global status of clinical study programs to senior management
• Contributing to initiatives and process improvement work streams, including process mapping of CROs

• Leads or supports the execution of all studies for a biosimilar program. Includes, but not limited to, PK/PD studies, global pivotal studies, chart reviews, region-specific studies, and device studies as appropriate
• Oversee the development of study timelines and budgets for studies within a biosimilar program
• Leads or co-leads (with Clinical Data Management) a cross functional team to review clinical study data to ensure high quality deliverables from the CRO
• Review and contribute to the creation of study documents, eg, synopsis, protocols, study plans, and Clinical Study Reports (CSR)
• Contribute to the execution and oversight of the feasibility process including the development of the site list
• Participate in the set-up of study vendors including development of process flow, scopes of work, and budget review
• For clinical logistics managed, contribute to the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications/devices. For outsourced clinical logistics, contributes, in collaboration with the CRO, for the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications
• Support global recruitment forecasting, global enrolment, and any recruitment enhancement initiatives
• In partnership with the CRO, help organize investigator meetings and study training (eg, CRA training)
• Contribute to inspection readiness activities (eg, TMF review, story board generation)
• Supports internal audit and regulatory agency inspection readiness activities (eg, TMF review)
• Supports / Leads the GCST, ensure operational consistency and standards across all clinical studies within a biosimilar program
• Identification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CRO
• Ensure timelines and deliverables are communicated cross functionally and at the CRO
• Communicate study status to management
• Contribute to development and maintenance of policies, SOPs, and associated documents
• Represent the function by contributing to initiatives for the continuous improvement of clinical study execution

• Day-to-day oversight of study start up/execution/close out activities in partnership with CRO and third-party suppliers
• Along with the CRO, study-related documents, plans, site lists and timelines
• Presentations to management and external audiences (when appropriate)
• Recommendations for process improvement initiatives

• Bachelor’s degree & 5 years of directly related experience
• OR
• Master’s degree & 3 years of directly related experience
• OR
• Doctorate degree & 2 years of directly related experience
• Experience with oversight of clinical research organizations (CROs)
• Experience in leading cross-functional teams

• 7-9 years work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Experience in oversight of outside vendors (CROs, central labs, etc)

* CO/NYC candidates might not be considered