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Job #03060

About our client Our client is the clinical trial services division of a leading academic institution that has developed a reputation for developing some of the most advanced medical research in the world. The company has an experienced management team and employee base that is committed to the highest standards of integrity and to improving the lives of patients and their families. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Clinical Trial Manager North Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Work in a matrix management environment 2) Serve as an expert resource to Project Team members 3) Oversee and facilitate the development and implementation of tools 4) Plan and strategize for managing sites and clinical monitoring activities for clinical research projects in assigned therapeutic area(s) 5) Serve as a Supervisor for assigned Clinical Operations staff within assigned therapeutic area 6) Participate as a member of therapeutic core team with faculty leader, Operations Manager and other functional group key representatives 7) Supervise staff activities 8) Collaborate with clinical operations personnel to identify current and anticipate long-term staffing resource needs 9) Assess assigned staff on work assignments, utilization and productivity 10) Develop written performance standards for Clinical Operations personnel 11) Conduct performance evaluations for assigned staff 12) Work with internal and external training resources (as required) 13) Ensure that all staff assigned are up-to-date on their required training (non-study specific) including SOPs, ICH/GCP and field-based training 14) Support therapeutic area and strategic planning 15) Coordinate the standardization and maintenance of status reports and other information sources 16) Facilitate communication with global partners and key therapeutic area investigators when issues arise that affect multiple projects and/or the entire therapeutic area 17) Work with the Project Leader to facilitate cross-functional team and multiple business-partner communication for proactive study-wide problem solving (regarding study progress and trial issues) 18) Assist with coordinating and prioritizing team efforts 19) Assess overall project metrics and study timelines across the therapeutic area in coordination with project leaders 20) Identify and notify appropriate parties of emerging out of scope activities, project change orders and study guidelines 21) Evaluate impact on resource needs, study processes and related documents 22) Collaborate with the therapeutic area management, proposal writing personnel and the proposal Project Leader in the development of scope of work, associated budget and timelines for new business proposals (as required) 23) Participate in the development of protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual (as required) 24) Provide input for the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process as well as related data tools and status reports 25) Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on an interim basis (as needed) to move project deliverables and timelines forward 26) Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams 27) Provide advice and guidance to team members for assessment, resolution and documentation of both routine as well as complex site and study issues 28) Interview job candidates and make hiring recommendations for Clinical Operations positions 29) Handle new business development 30) Attend appropriate clinical team leadership meetings, department meetings and organizational meetings 31) Train, coach and evaluate site management and Clinical Monitoring Team members 32) Direct and manage competing complex individual and team clinical trial activities to meet objectives, timelines and budget 33) Collaborate with internal and external partners to achieve departmental and organizational goals 34) Manage other general activities Requirements 1) Degree (4 year) providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist 2) Allied Health Degree (Respiratory Therapy, Radiological Technology, Licensed Practical Nurse), Master’s in Public Health or Bachelor's degree will be considered (depending upon work experience) 3) Minimum 5 years of relevant clinical research experience including 4 years directly related to clinical trials research with at least 2 years of clinical trial monitoring and 2 years of clinical trial lead experience 4) Minimum 1 year of supervisory experience 5) Understanding of departmental SOPs and systems 6) Knowledge of FDA regulations, ICH guidelines, and GCPs as well as their application to clinical trials 7) Strong knowledge of clinical research trial operations 8) Superb knowledge of medical terminology 9) Good technical knowledge as well as procedure monitoring and practice skills. Excellent technical spelling and grammar skills including reviewing and proof reading of business 10) Strong personnel management and team leadership skills documents and communications 11) Excellent interpersonal skills 12) Ability to write, speak and present strategies clearly as well as concisely in a variety of communication settings and styles 13) Ability to establish and promote positive business relationships 14) Customer service oriented 15) Proficiency in computers (MS Office, EPM, CTMS, etc.) as well as ability to learn and use computer applications 16) Ability to collaborate with team members to achieve trial-specific goals within specified timelines 17) Ability to use critical thinking skills (independently) to effectively solve problems and use conceptual thinking to anticipate impact of decisions 18) Knowledge of scientific application to clinical trials research 19) Willingness to travel – some for consecutive nights (up to 25%)