Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
Role is responsible for the implementation and oversight of clinical study or program operations by organizing and coordinating with other relevant parties the planning, implementation, management, execution and completion of clinical studies or programs according to applicable regulations and guidance, ICH and GCP, and Valeant Research & Development SOPs within agreed-upon timeframes and budget. Also responsible for effective communication within the corporation (and with external entities, where appropriate) of the issues and actions related to the successful completion of these studies. May serve as the primary project team representative for Clinical Operations.
Job Dimensions: May supervise direct/indirect reports including Manager, Clinical Operations, Senior Clinical Research Associates and Clinical Research Associates (Sr. CRAs and CRAs) and clinical project assistants.
• Manage the development process for critical study documents (e.g., protocol, amendments, IB, ICF, and CRFs). Will also work closely with members of other functional areas to provide input on study-related documents and issues (DMP, SAP, drug supplies, etc.).
• Provides clinical operations input in the identification, evaluation, and selection of CROs and vendors (e.g., central labs, central IRB, IVRS, etc.).
• Manage the identification, evaluation, and selection of investigators/sites.
• Ongoing assessment, evaluation and management of internal and external resources.
• Ensure study supply requirements are met.
• Ensure appropriate communication with and maintenance of clinical study sites including training of site personnel in the study protocol and other study-specific procedures.
• Supervise clinical operations team to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Valeant SOPs.
• Communicate with relevant global team members, other Valeant departments (e.g., Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilence and Drug Safety, and Clinical Supplies), and external consultants to ensure study objectives are being met and provide the operations director and/or senior management with timely updates on progress and changes in scope, schedule, and resources.
• Organize investigator and expert meetings relevant to the indication and assist with the organization and management of DSMBs and Data Review Committees.
• Prepare study timelines and budgets and ensuring study execution is aligned with these targets.
• Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Valeant SOPs.
• Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.) during study start-up and throughout the life of the project to ensure that procedures are followed in an appropriate and consistent manner.
• Oversee the preparation of procedures for the conduct and monitoring of clinical research such as Clinical Monitoring Plans, procedures for reporting of adverse events, CRF completion guidelines, Study Manual, etc.
• Liaise with PVG and provide clinical operations support and guidance for the ongoing surveillance of the safety of patients in clinical trials by reviewing reported AEs and SAEs and assure proper reporting of the events to the IRBs/REBs.
• Liaise with Data Management to review data discrepancies and ensure that data clarification forms (queries) are appropriately handled by the CRAs and responded to by the site/investigator in a timely manner. May assist in the review of queries to determine criticality of the DCF during data clean-up and lock process.
• Liaise with study site personnel and clinical investigators to provide study related guidance and answers to operational issues. Budgets and Forecasts:
• Provide assistance to the Head of Clinical Operations in working with Business Operations to forecast study expenditures and resourcing needs.
• With guidance from theHead of Clinical Operations, review RFPs and proposals from external vendors.
• Ensure subordinates and vendors manage and monitor study related expenses to meet forecast.
• Ensure timely communication of any variances to budget forecast to the Sr. Director or Director of Clinical Operations.
• Provide Clinical Operations support in the timely coordination and execution of clinical study reports.
• Assist in the review of regulatory reports to ensure that reports accurately reflect proper interpretation of the clinical study findings.
• Assist to ensure annual IND and IB updates are completed in an accurate and timely manner.
• Provide Clinical Operations support to the Regulatory Affairs department. Leadership:
• Manage in-house team of Managers and CRAs for one or more studies to ensure execution of all studies in a timely and efficient manner.
• Provide leadership, training, and development support to the study team.
• May lead meetings (face-to-face, teleconferences, etc.) with external vendors ensuring problems are identified and issues are resolved quickly and efficiently.
• May serve as a representative on internal committees/teams for Clinical Operations or cross-functional activities.
• Foster a dynamic, matrixed working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging study team members to meet and/or exceed expectations.
• Encourage professional growth of personnel through regular training sessions, and by acting as a resource to clinical staff. May lead training sessions.
• Provide guidance and comments on SOPs revisions. May act as a leader of a SOP sub-committee for SOP revisions.
• May visit sites with Managers and/or Clinical Research Associates as needed to provide hands-on training as well as to discuss study related issues and problems with the Principal Investigator and/or site staff. Professional Enrichment:
• Attend related courses, seminars and meetings including SOP training.
• Maintain training records.
• Read professional journals and publications to stay abreast of current scientific knowledge in particular therapeutic area as well as in applicable guidelines and regulations.
• Obtain information from the field on relevant new scientific developments and identify needs for staff training, if applicable.
• Share/present knowledge and information with appropriate departmental, project, or study team members for training purposes.
• Strong knowledge of Good Clinical Practices (GCP), clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance, and clinical data management.
• Minimum 10-12 years experience in the industry with approximately 6-8 years managing clinical trials.
• 5 – 6 years experience in managing and training clinical personnel (Managers, Sr. CRAs, CRAs, project assistants).
• Strong planning and organizational skills with ability to multi-task and plan activities as it relates to management of clinical trials.
• Experience leading and working within cross-functional teams.
• Experience in managing CROs and external vendors.
• Excellent written and verbal communication skills and strong interpersonal skills in order to interface with physicians, outside vendors, consultants, team members and various audiences.
• Ability to problem solve, build teams, and to lead and motivate others.
• Effectively work independently as well as within a team matrix.
• Financial management skills as applicable to overseeing project expenditures and forecasts.
• Advanced computer skills (Microsoft applications, spreadsheets and data displays, etc.)
• Willing and able to travel.
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Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.