Manager, Study Management - Biosimilars

About the Company:

AllSTEM Connections is seeking a Manager Study Management - Biosimilars to work remotely in PST/MST/CST/EST US time zones. This is a three-year (36 month) contract position. Hourly rate is up to $71/hour. M-F, 8AM - 5PM.

About the Role:

The purpose of this role is to be the 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. This person will oversee the quality and scientific integrity of clinical operations for studies at a global level and collaborate with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables.

Responsibilities:

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

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• 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
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• Oversee the development of study timelines and budgets for studies within a biosimilar program
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• Leads or co-leads (with Clinical Data Management) a cross-functional team reviewing clinical study data to ensure high quality deliverables from the CRO
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• Review and contribute to the creation of study documents, e.g., synopsis, protocols, study plans, and Clinical Study Reports (CSR)
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• Contribute to the execution and oversight of the feasibility process including the development of the site list
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• Participate in the set-up of study vendors including development of process flow, scopes of work, and budget review
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• For clinical logistics managed by the Company, contribute to the overall study drug management including management (if applicable) of reference product, pre-medications, and other supportive medications/devices
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• 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
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• Support global recruitment forecasting, global enrolment, and any recruitment enhancement initiatives
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• In partnership with the CRO, help organize investigator meetings and study training (e.g., CRA training)
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• Contribute to inspection readiness activities (e.g., TMF review, story board generation)
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• Supports internal audit and regulatory agency inspection readiness activities (e.g., TMF review)
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• Supports / Leads the GCST, ensure operational consistency and standards across all clinical studies within a biosimilar program
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• Identification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CRO
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• Ensure timelines and deliverables are communicated cross functionally and at the CRO
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• Communicate study status to management
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• Contribute to development and maintenance of policies, SOPs, and associated documents
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• Represent the function by contributing to initiatives for the continuous improvement of clinical study execution
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Outputs:

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

Basic Qualifications

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

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• 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)
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• Experience in oversight of outside vendors (CROs, central labs, etc.)
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Knowledge

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• Knowledge of relevant therapeutic or product area
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• Clinical research experience obtained working on industry-sponsored global clinical trials
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• Excellent oral and written communication skills
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• Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
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• Experience working in a global, matrix organization on global clinical development programs
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• Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
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• Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
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• Solid understanding of Biopharmaceutical/Healthcare Compliance
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• Proven ability to anticipate and resolve problems
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• Excellent interpersonal and organizational skills
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• Professional collaboration and leadership skills
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• Experience anticipating and resolving problems
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• Experience writing and presenting clearly on scientific and clinical issues
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• Experience collaborating and leading cross-functional teams
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