在罗氏，我们鼓励每位同事展现真实的自己；我们欣赏独特且出众的品质。罗氏的文化鼓励积极的表达、开放的对话和真诚的连结，在这里，你将因为做自己而被重视、接纳和尊重，并得到个人的提升和职业的发展。所有的这一切，都是为了更好地预防、阻止和治愈疾病，并确保医疗资源的可及性和可持续性。欢迎加入罗氏，一个重视每种声音的地方。 职位 Job Title: Clinical Study manager- local studies Location: (HO) Mumbai Role Summary: Provides leadership to study team, local strategic planning and operational delivery of assigned local clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments. How does the role serve the patients? • Provides hands-on experience to KOLs on Innovative treatment through local phase 4, non-interventional studies, Investigator initiated studies, Real world evidence generation, Compassionate use program, Post trial access program. • By providing early access to innovative treatment to Indian patients. • By generating robust safety as well as efficacy data on Indian patients through participation in the clinical trials which in turn facilitates regulatory approvals for Roche Innovative products. Accountabilities Has full accountability and oversight for all assigned studies at country level (local studies) in accordance with the overall project plan, manages and maintains accurate study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system. • Leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides global teams with feedback from an Affiliate perspective • Works with relevant global study team to manage day to day activities of the study, including monitoring report review, problem solving, issues escalation , timely closure of non-productive studies and tracking of safety procedures • Plans and executes country study goals and commitments, and ensures compliance to relevant processes, Roche quality and safety standards, regulations, timelines and budget commitments. • Provides operational oversight of Investigator-initiated studies and Compassionate Use studies in terms of Roche quality and safety standards, regulations, timelines and budget allocation. • Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required. • Coaches and provides support to responsible study team members by maintaining effective communication • Provides study oversight, leadership and support to Clinical Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required. • Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies (including translations, as applicable) • Provides inputs to and/or develops study related materials such as Monitoring plans, recruitment plans and study Newsletters • Supports/coordinates the negotiation of site budgets within Fair Market Value guideline, budget plans and provide oversight for site payments as per contract, as required. • Participates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies. • Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies. • Participates in overall therapeutic area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required. • Performs/coordinates for Health Authority presentation for the study/protocol amendments. • For Local Studies, provides the leadership and clinical operations expertise for the local study team. Internal Stakeholders All Medical functions, Procurement, Legal, Finance External Stakeholders HCPs and HCOs, Regulatory authorities, Industry Bodies, Patient Support Groups and Vendors Functional Competencies Knowledge of ICH-GCP, Indian Regulations, multiple therapy area knowledge, technical expertise in the field of clinical operation, vendor management Behavioral Competencies Exhibition of Roche Core Values, Exhibition of Servant Leadership, Patient centricity in decision making, Strong Collaboration and Networking skills, Inspiring and Influencing Eligibility Criteria (Qualification and Experience) • University degree or equivalent; professional qualification preferably in a medical/science related field Pharmaceutical medicine training highly desirable • Higher degree and / or specialist accreditation desirable • Employee has completed minimum 1 year with Roche Pharma (Applicable for internal hire) • Employee having an overall experience of minimum 5 years in Pharmaceutical / Biotech / Clinical Research industry with minimum 5 years in Clinical Operations. • Clinical operations and quality assurance • Job Location: Mumbai (HO) • Willingness to relocate 我们是谁 打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。 让我们一起，构建更健康的未来。 罗氏提供平等的职业发展机会。