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location: Newbury Park, California
job type: Contract
salary: $60.00 - 64.29 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- 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 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, 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
qualifications:
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
- 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
skills: FDA, CTMS (Clinical Trial Management Systems), ICH Regulations, TMF, Clinical Trial Supply Strategy
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
