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If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you! 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 CROEnsuring implementation of trial(s) in partnership with CRO in accordance with applicable SOPs and ICH/GCP guidelinesExecution of clinical studies with high-quality, on time, and within budgetContribute to the authoring and review of key study documentsDay to day management of study execution including management of study timelinesManaging program-level operational issues and oversight of study team issue escalationSupports / Leads the Global Clinical Study Team for the allocated program(s)Communicating global status of clinical study programs to senior managementContributing to initiatives and process improvement work streams, including process mapping of CROsLeads 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 appropriateOversee the development of study timelines and budgets for studies within a biosimilar programLeads or co-leads (with Clinical Data Management) a cross functional team to review clinical study data to ensure high quality deliverables from the CROReview 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 listParticipate in the set-up of study vendors including development of process flow, scopes of work, and budget reviewFor 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 medicationsSupport global recruitment forecasting, global enrolment, and any recruitment enhancement initiativesIn 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 programIdentification and resolution of cross-functional study / program issues within a biosimilar program or escalated from the CROEnsure timelines and deliverables are communicated cross functionally and at the CROCommunicate study status to managementContribute to development and maintenance of policies, SOPs, and associated documentsRepresent 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 experienceExperience 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 areaClinical research experience obtained working on industry-sponsored global clinical trialsExcellent oral and written communication skillsProven ability to lead, manage, and motivate others in a complex, multi-functional environmentExperience working in a global, matrix organization on global clinical development programsKnowledge to represent and evaluate strategies for clinical development and to critically evaluate outside expert adviceBroad knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelinesSolid understanding of Biopharmaceutical/Healthcare ComplianceProven ability to anticipate and resolve problemsExcellent interpersonal and organizational skillsProfessional collaboration and leadership skillsExperience anticipating and resolving problemsExperience writing and presenting clearly on scientific and clinical issuesExperience 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.