• Builds and sustains long-lasting relationships with existing and potential clients (sponsors and CROs) • Builds and sustains long-lasting relationships with Investigators and Medical Institutions representatives • Assesses feasibility of research protocols based on knowledge and experience • Supervises the conduct of clinical trials in accordance with ICH GCP • Monitors individual stages of budget negotiations and research timelines • Set up meetings with Investigators, pharmaceutical and CRO companies' representatives

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • For the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. • Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture. • Verifies site compliance with electronic data capture requirements. • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information related to IP. • Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. • Supports subject/patient recruitment, retention and awareness strategies. • Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

• Facilitates Credentials Verification Organization (CVO) provider application and data collection • Executes credentialing application processing and primary source verification for new applicants and re-credentialing • Assures applications are correct and complete • Works with credentialing auditors to correct deficiencies • Organizes and maintains provider data and files • Processes applications timely to meet quality benchmarks • Maintains awareness of The Joint Commission (TJC), NCQA, and CMS compliance guidelines • Demonstrates excellent professional communication skills while collecting information and resolving issues • Maintains privacy and confidentiality in all aspects of work

Role Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections. Qualifications - B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area. - Further formal education in quality management or business management is preferred. Requirements - Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections. - Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools. - Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements. - Has delivered effective CAPA management solutions. - Has worked with risk management tools and processes within the clinical quality framework. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days. Other Activities - Provides input into GCP Quality and Compliance Council. - Assesses and provides input to strengthen company programs/strategies (e.g. QCV) with an aim to increase Inspection Readiness. - Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed. Skills - Superior oral and written communication skills in an international environment. - Excellent project management and organizational skills. - Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. - Ability to lead cross-functional teams of business professionals within and outside our Research division. - Able to act urgently for worldwide health authority inspection matters. - Ability to analyze, interpret and solve complex problems. - Ability to think strategically, critically, and objectively with creativity and innovation. Required Skills - Adaptability - Clinical Quality Management - Clinical Study Design - Clinical Trials Monitoring - Data Analysis - Emerging Risks - Good Clinical Practice (GCP) - Process Improvement Projects - Regulatory Compliance - Regulatory Inspections - Risk Management - Stakeholder Relationship Management - Strategic Thinking - Training and Development Preferred Skills - Oncology