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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: Fort Worth, Texas job type: Contract salary: $80.00 - 85.71 per hour work hours: 9 to 5 education: Bachelors responsibilities: Major Responsibilities:Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity in support of one or more projects.Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required.Develop Protocol Monitoring Plan (PMP).Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities.Prepare, coordinate, deliver, and track protocol specific training for CSMs and site personnel.Initiate Investigational Product shipment requests, resupply, and coordinate reclamation of supplies from sites for assigned trial(s).Create and maintain user account worksheets for provisioning all site personnel for assigned trials into required systems (e.g., EDC, IRT, training portals).Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation. Major AccountabilitiesLead the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CDMA. Each Clinical Operations Lead will be assigned 2-3 clinical trials of low to medium complexity in support of one or more projects.Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.Ensure consistency of Company's processes and procedures across sites and studiesContribute operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc.Develop Protocol Monitoring Plan (PMP)Follow study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverablesLead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, milestones, and status of CSM activitiesCoordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulationsCoordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMsInitiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies for sites on assigned trial(s)Create and maintain user account worksheets for provisioning all site personnel and CTT members for assigned trials into required systems (e.g. EDC, IRT, training portals)Actively participate on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriateFacilitate communication between CTT and sites throughout the trialProvide progress reports to CTT and upper management routinelyProactively identify potential/actual issues and risks, escalate to CTT and management as appropriate, and contribute to mitigationLeads/participates in department and cross-functional process improvement initiatives to improve operational efficienciesAchievement of project specific milestones for assigned trials as defined in overall CDMA objectives: First Patient First Visit (FPFV), Last Patient First Visit (LPFV), Last Patient Last Visit (LPLV), and Database Lock (DBL)High quality/compliance in assigned trials as defined in overall CDMA objectivesAdherence to processes and proceduresProactive identification and mitigation of issues/risks qualifications: Bachelor's Degree in life science; medical, pharmaceutical, biology, chemistry degree preferred.The ability to fluently read, write, understand and communicate in English.5 years of direct experience as Clinical Operations Lead or clinical trial management experience.Travel requirements: 5-10% (paid for by the client)Field clinical monitoring, site management (e.g., study coordinator), or clinical research experienceProject Management experience preferredExcellent verbal and written communication, problem solving skills and team orientation skills: Clinical research, GLP (Good Laboratory Practice), Clinical Data Management, Clinical Study Design, CTMS, CTMS (Clinical Trial Management Systems), SIV (Site Initiation Visit), ICH Regulations, TMF, Clinical Supply Chain, 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). Applications accepted on ongoing basis until filled.