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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Study Management Manager
Remote, CA US
Posted: 01/21/2025
2025-01-21
2025-02-24
Employment Type:
Contract
Job Category: Operations and Development
Job Number: 4208
Job Description
Biosimilars – Manager Study Management (Biosimilars – MSM)
Purpose:
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
- 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
- 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)
- 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
- Team leadership
- Strong written and oral communication
- Flexibility
- Initiative
- Problem solving
- Project management
- People management
- Decision making
- Scientific/technical excellence