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Study Management Manager

Remote, CA

Posted: 05/29/2025 Employment Type: Contract Job Category: Operations and Development Job Number: 4403

Job Description

Biosimilars – Manager Study Management (Biosimilars – MSM)

Purpose:
  • 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
Responsible for:
  • 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 by the company, 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, storyboard 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
Basic Qualifications
  • 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
Preferred Qualifications
  • 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)
Knowledge
  • Knowledge of relevant therapeutic or product area
  • Clinical research experience obtained working on industry-sponsored global clinical trials
  • Excellent oral and written communication skills
  • Proven ability to lead, manage, and motivate others in a complex, multi-functional environment
  • Experience working in a global, matrix organization on global clinical development programs
  • Knowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert advice
  • Broad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines
  • Solid understanding of Biopharmaceutical/Healthcare Compliance
  • Proven ability to anticipate and resolve problems
  • Excellent interpersonal and organizational skills
  • Professional collaboration and leadership skills
  • Experience anticipating and resolving problems
  • Experience writing and presenting clearly on scientific and clinical issues
  • Experience collaborating and leading cross-functional teams
Key Competencies
  • Team leadership
  • Strong written and oral communication
  • Flexibility
  • Initiative
  • Problem solving
  • Project management
  • People management
  • Decision making
  • Scientific/technical excellence
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