Biosimilars - Manager Study Management (Biosimilars - MSM)

Spectraforce Technologies; Thousand Oaks (CA); A distancia; USD 130.000 - 165.000; Jornada completa

Descripción de la vacante

Spectraforce Technologies, Inc. is seeking a Biosimilars - Manager Study Management (Biosimilars - MSM) for a 12-month remote assignment. You will lead global studies from design to close-out in partnership with CROs, ensure quality and timelines, and manage budgets.

The role requires overseeing study teams, developing timelines and documents, and communicating status to senior management. This position emphasizes ICH-GCP compliance, cross-functional collaboration, and process improvements

Formación

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

Responsabilidades

• Lead global biosimilar studies in partnership with CROs to ensure on-time, on-budget execution.
• Oversee trial activities to ensure adherence to SOPs, ICH/GCP guidelines and quality standards.
• Manage study timelines, budgets, and issue escalation across global teams.

Conocimientos

CRO oversight experience

Cross-functional team leadership

Clinical trial management

Global study management

Communication skills

Educación

Bachelor's degree

Master's degree

Doctorate degree

Descripción del empleo

Job Title: Biosimilars - Manager Study Management (Biosimilars - MSM)

Duration: 12 months

Location: Remote

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

Key Activities:

• 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 client, 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

Outputs:

• 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

Top 3 Must Have Skills:

• Comfortable navigating ambiguity; be able to assume ownership of a task with limited guidance (i.e., come to me with questions, but don't necessarily expect "hand holding")
• Would like to see linear progression with increasing responsibility in roles
• Experience working for a Sponsor (eg, working for client or another pharmaceutical/biotech company) and for Contract Research Organizations (CROs).

At the task level, the ideal candidate will have experience in the following activities:

• Informed Consent Form (ICF) review
• Sample management/tracking
• eTMF (Trial Master File) experience
• Data listing/patient profile review; ability to work with data management
• Inspection readiness/support activities

Possible Extension:

• No

Red Flags:

• Please review description and posting details. Scrubbed resume attached of former hire from this role

Interview Process:

• Video conference 2-3 rounds