job summary: Primary point of contact to lead, manage and coordinate, in partnership with the ContractResearch Organization (CRO), the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCPOversee the quality and scientific integrity of clinical operations for studies at a global levelCollaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables location: Telecommute job type: Contract salary: $65.00 - 71.43 per hour work hours: 9 to 5 education: Bachelors responsibilities: Responsible for: 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 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 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 Outputs: Day-to-day oversight of study start up/execution/close out activities in partnership with CRO and third-party suppliersAlong with the CRO, study-related documents, plans, site lists and timelinesPresentations to management and external audiences (when appropriate)Recommendations for process improvement initiatives qualifications: Required: Bachelor's + 5 years related experience OR Master's + 3 years related experience OR Doctorate + 2 years related experience.Informed Consent Form (ICF) reviewSample management/trackingeTMF (Trial Master File) experienceData listing/patient profile review; ability to work with data managementInspection readiness/support activitiesCRO oversight experience.Experience leading cross-functional teams. Preferred: 7-9 years life sciences/medical field experience (biopharma clinical research).Experience overseeing external vendors (CROs, labs, etc.). #LI-CV1 skills: MS-WORD, MS-EXCEL, MS-Powerpoint, Study Planning 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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 with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. 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.