Clinical Program Scientist

Job description

• Manages or assists in the planning, implementation, and execution of a clinical research study(ies). • Manages clinical outsourcing to CROs and other vendors such as IVRS, labs, IRBs, etc. • May author, review and approve various study related documents and plans. • Leads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study. • Leads and/or assists the study team to design, develop and deliver the clinical study to agreed upon timelines. • May assist in authoring/contributing to clinical study documents and study related plans developed by Clinical CRO and vendors. Responsibilities- • Leads and/or assists the study team to execute the clinical study in accordance with the clinical development plan/strategy and timelines. • Contributes to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines. • Leads/assists in oversight of the identification and selection of investigator sites. • Assists and/or participates in planning and conduct of investigator’s meetings. • Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team. • Collaborates with the cross functional team on selection and potentially management of clinical vendors. • Liaises and coordinates with document specialists regarding study files. • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions. • May support or co-manage larger complex trials as necessary. • Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements. • Monitors the status of clinical data collection of assigned clinical studies. • May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance. • Reviews clinical monitoring reports and correspondence related to monitoring visits. • Responsible for maintaining tracking information in the clinical trial management system and confirming resolution of data quality issues with the CRO. • Ensures effective communication between Shire and the Clinical CRO. • Reviews and approves study plans. • Oversees and monitors the management of the clinical study, ensuring it is conducted in accordance with the approved study plans. • May provide periodic status reports regarding study timelines, budget issues, accruals, etc. to Global Clinical Operations Lead (GCOL) as requested. • May develop and/or monitor budget for clinical study (investigational sites and vendors). • May generate or assist in critically evaluating proposals, contracts, and change orders from CROs and other vendors. • Develops knowledge of therapeutic area, current medical practice and industry regulations in order to ensure best practice across all activities. • Supports departmental initiatives and process improvements. • Bachelor’s degree or nursing qualification is required. • Scientific/health care field preferred, but not required. • Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization. Key Skills, Abilities, and Competencies- • Strong knowledge of applicable computer and project management software packages. • Familiarity with project management software or tools. • Familiarity with financial budgeting and forecasting or reporting. • Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines. • Ability to work successfully within a cross-functional team and a matrix organization. • Excellent written and oral communication skills. • Ability to interact with investigators, vendors, and internal colleagues. • Knowledge of current regulatory requirements and guidelines governing clinical research. Complexity and Problem Solving- • Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints. • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands. • Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner. With Regards Ricky Bansal 732-429-1925 A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.