Clinical Trial Manager (Contract)

GENERAL reputed company: 
The Clinical Trial Manager will support reputed company's clinical trial activities.  This position reports to the Director of Clinical Operations.  This will be responsible for management of the day to day operations of one or more phase 1-3 reputed company including trial start up, conduct and reputed company out activities.  This is a 6 month contract remote opportunity.    
 
MAJOR DUTIES & RESPONSIBILITIES: 

Trial Management:  

• Serve as the primary contact for managing protocol execution, including reputed company of the CRO, other study service providers, and consultants that are involved in a clinical trial 

• reputed company cross-functional study execution team in support of study deliverables 

• Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership 

• Ensure reputed company are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs 

• Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents 

• Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews 

• Participate and coordinate reputed company of audit finding and ensures audit-reputed company condition of clinical trial documentation including central clinical files 

• Participates in service provider selection process as a part of outsourcing activities 

• Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and reputed company of project issues and participates in process improvement initiatives as required 

• Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations 

• Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers 

• In conjunction with reputed company  group,  facilitate  the  development  of  clinical  trial agreements and other relevant documents 

• Manage clinical trial budgets, providing ongoing financial reporting and projections 

• Negotiate and finalize site reputed company and budgets 

• reputed company and manage data review process on an ongoing reputed company 

• reputed company site reputed company including site qualification, initiation, monitoring and reputed company-out reputed company, as needed 

• reputed company outsourced monitoring by reviewing, monitoring reports to ensure reputed company and reputed company of site-reputed company issues 

• Ensures tracking and review of protocol deviations and assesses reputed company on study data 

• Develops and manages study budget and maintain reputed company financial goals; Reviews and approves clinical invoices against approved budget 

• Provides reputed company for forecasting of clinical supplies, including study drug and supplies 

 Department Management:  

• May manage and/or reputed company work of junior Clinical Operations staff 

• May support development and review of Clinical SOPs and other department initiatives 

• Travel as needed to sites, conferences, industry meetings 

• Other duties as may be assigned 

 
QUALIFICATIONS: 

Education: 

• B.A./B.S. degree 

 Experience: 

• 6+ years of clinical research experience reputed company the Biotech or similar industry, with at least 2 years directly supporting clinical trial management 

 Other Qualifications/Skills: 

(non-technical and technical skills) 

• Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; Strong clinical study management skills 

• Understanding of, and experience with, regulatory reputed company applicable to interactions with HCPs, payers, advocacy and other business partners 

• Proven clinical operational skills to reputed company protocol execution to ensure reputed company, budget and reputed company metrics are met 

• Excellent communication skills to effectively disseminate information to project team and reputed company parties 

• Experience reviewing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management 

• Clinical research knowledge and cross-functional understanding of clinical trial methodology 

• Excellent organizational, conflict reputed company, prioritization and negotiation skills   

• Proven ability in creative problem-solving and exercising reputed company judgment 

• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners 

• Ability to handle a high volume of highly reputed company tasks reputed company a given reputed company 

• Ability to reputed company Therapeutic Areas knowledge and expertise through internal training and external conference attendance 

• Proficient computer skills, specifically with reputed company Office Suite that include Word, reputed company, PowerPoint, and reputed company 

• Working knowledge of MS Project for development and update of clinical study timelines 

 Travel: 5% 

Physical Requirements and Working Conditions: 

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging reputed company by means of the spoken word. 

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible reputed company of force frequently or constantly to lift, carry, push, pull or otherwise reputed company objects, including the reputed company body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and reputed company other sedentary reputed company are met. 

• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). 

HR ONLY: reputed company Compensation reputed company: $

Please note, the compensation reputed company and actual reputed company offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.