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Sunnyvale, CA

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General Position Overview:The Clinical Trial Manager (CTM)/Sr. CTM (level is depending on experience) is the primary operational contact for the study and leads the cross-functional team for execution of the study. The CTM provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs). The CTM should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study (ies) with effective communication across organization. This position may include line management responsibilities. Key Accountabilities/Core Job Responsibilities: Study Planning and Conduct: Responsible for all operational aspects and progress of clinical trial from a study planning activities to study execution including ongoing tracking all applicable performance metrics and quality indicatorsServes as an escalation point and resource for internal/external teams and investigational sites; partners with cross functional groups to achieve deliverablesOversees/facilitates country and site feasibility/selection processes Develops/oversees subject recruitment/retention strategy and related initiativesProvides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc. Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriateResponsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities. Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations)Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packagesEnsures that all aspects of GCP compliance and audit readiness are maintained throughout trial conductConducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as neededProject Management: Creates, manages, measures, and reports timelines for milestone deliverablesProactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders Prepares metrics and updates for management Oversees internal team meetings, investigator meetings, and other trialu00ac specific meetingsParticipates in the development, review, and implementation of departmental SOPs, WIs, initiatives and processesMay manage/mentor direct reports and team members, and perform performance appraisals as assignedFinancial Planning and Management:Strong understanding of the cost drivers and are accountable for the development, management, reconciliation of overall study budget(s) and resource allocationCollaborates in the development/management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelinesReviews/approves vendor invoices and manages accruals and payment process for all clinical trial vendors including investigative sitesMaintains completion of required corporate training on standards, policies, work instructions by due datePerform other work related duties as assignedEducation and Experience Requirements: BA/BS or equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD) Minimum 7-8 years of clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting with 1 year of supervisory experience for Sr. CTM (at least 1 year at a Sponsor company is preferred for both levels)Experience in interactions with outside vendors, e.g., CROs and other vendorsFamiliar with advanced concepts of clinical research and able to work effectively in a team/matrix environmentDemonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a Clinical Development PlanLine management experience is required for Sr. CTMExperience in oncology preferred Experience in global trials preferredConsideration for Sr. title will be based on previous experience and/or education About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffingu00ae Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please **** or email **** for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.nn 

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