Experienced Clinical Trials Manager

Job Description: Working in a matrix management environment, serve as an expert resource to project team members to oversee and facilitate the development and implementation of tools, plans and strategies for managing sites and clinical monitoring activities for clinical research projects in assigned therapeutic area(s). Serve as supervisor for assigned Clinical Operations staff within assigned therapeutic area. Participate as member of therapeutic core team with faculty leader, operations manager, and other functional group key representatives. Note: This is an in-house position. WORK PERFORMED: Supervision of Staff Activities - 40% ' Serve as supervisor for assigned Clinical Operations staff within therapeutic area(s) and assess assigned staff on work assignments, utilization and productivity. ' Develop written performance standards for Clinical Operations personnel. ' Conduct performance evaluations for assigned staff. ' Work with internal and external training resources as required, ensure that all staff assigned, are current with their required training (non-study specific) including SOPs, ICH/GCP, and field-based training. Therapeutic Area Support and Strategic Planning - 20% ' Coordinate the standardization and maintenance of status reports and other information sources. ' Facilitate communication with global partners and key therapeutic area investigators when issues arise that affect multiple projects and/or the entire Therapeutic Area. ' 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. ' Assist with the coordination and prioritization of team efforts and assess overall project metrics and study timelines across the Therapeutic Area. In coordination with Project Leaders, identify and notify appropriate parties of emerging out of scope activities, project change orders and study guidelines. Evaluate impact on resource needs, study processes and related documents. ' Collaborate with clinical operations personnel to identify current and anticipate long-term staffing resource needs. ' New Business Development - 20% ' 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. ' Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual as required. ' Provide input for the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports. Monitoring Activities - 10% ' Perform activities of Lead CRAs (Senior CRA and other monitoring staff) on an interim basis as needed to move project deliverables and timelines forward ' Provide expertise in managing sites and clinical monitoring activities utilizing advanced practices to assigned project teams. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues. Other General Activities - 10% ' Interview job candidates and make hiring recommendations for Clinical Operations positions. ' Attend appropriate clinical team leadership meetings, department meetings and organizational meetings. Education/Training: Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA), or Pharmacist. Completion of an allied health degree (e.g. Respiratory Therapy, Radiological Technology, Licensed Practical Nurse), Masters In Public Health, or Bachelor's degree will be considered depending upon work experience as described below. Advanced degree preferred Experience: Minimum of 5 years related clinical research experience including 4 years directly related clinical trials research experience to include at least two years clinical trial monitoring and two years of clinical trial lead experience. One year minimum of supervisory experience required. Strongly prefer clinical research experience in therapeutic area and three years supervisory experience, or an equivalent combination of relevant education and/or experience Required Knowledge, Skills and Abilities: ' Strong personnel management and team leadership skills ' Ability to train, coach and evaluate site management and clinical monitoring team members ' Ability to direct and manage competing complex individual and team clinical trial activities to meet objectives, timelines and budget ' Strong technical knowledge and skills for monitoring procedures and practices ' Strong knowledge of clinical research trial operations ' Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials ' Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications ' Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles ' Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented ' Ability to collaborate with team members to achieve trial-specific goals within specified timelines; ability to collaborate with internal and external partners to achieve departmental and organizational goals ' Proficient computer skills including MS Office, Word, Excel and PowerPoint, EPM, CTMS, etc.; ability to learn and use computer applications ' Ability to independently use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions ' Strong knowledge of medical terminology ' Knowledge of scientific application to clinical trials research ' Understanding of departmental SOPs and systems ' Ability to travel 25%, some for consecutive nights Learn more about company