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 Amgen, 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 / 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
Employee Value Proposition:
3 year contract
Unique industry opportunity
Industry experience
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
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $54.54/hr - $68.96/hr.
