4 Study Management Jobs

The responsibilities of the Clinical Research Associate at AstraZeneca involve ensuring the execution of Study Delivery processes by developing study reports tools, facilitating the study delivery system, and maintaining the system. As an expert in the field, you will be responsible for ensuring the delivery of a centrally managed study management service across clinical studies from start-up to reporting. Your role will also involve serving as the main contact and collaborating closely with the Document Management group until the Clinical Study Report is finalized. In addition, you will be responsible for initiating and maintaining the production of study documents, ensuring template and version compliance, as well as creating or importing clinical-regulatory documents into the Global Electronic Library according to the Global Document List. Collaboration with Data Management Center or Data Management Enablement representatives to facilitate the delivery of study-related documents will also be a part of your responsibilities. Managing and coordinating the tracking of study materials and equipment, monitoring administrative tasks during the study process, audits, and regulatory inspections according to company policies are also key aspects of the role. As a Clinical Research Associate, you will act as a technical owner within Patient Safety, demonstrating a deep understanding of processes and internal regulations. It is essential to keep your knowledge of best practices and new relevant developments up to date. Liaising with compliance team members to improve regulatory processes within the team and identifying opportunities to enhance the methodology and provide practical solutions for clinical development are also important responsibilities. Regarding People Management Responsibility, this role does not involve direct or indirect reports. The global remit for this position is limited to the own country. The ideal candidate for this position should possess a Bachelor's degree in a relevant discipline, experience in Study Management within a pharmaceutical or clinical background, and knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management. Desirable qualifications include an advanced degree within the field, professional certification, and an understanding of multiple aspects within Study Management. Key relationships to reach solutions include internal interactions with the Study management function and other AstraZeneca employees, as well as external collaborations with external service providers and regulatory bodies. AstraZeneca is committed to creating an inclusive and diverse team representing all backgrounds and perspectives, with a focus on industry-leading skills. The company values diversity and equality of opportunity and welcomes applications from all qualified candidates, irrespective of their characteristics. AstraZeneca complies with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements.,

As the Manager, Clinical Operations at Kenvue, you will be responsible for coordinating the operational aspects of Higher complexity clinical studies for Consumer Health products in India, APAC, or EMEA. Your role will involve collaborating with key stakeholders within the Clinical Operations global organization, local India leadership, Study directors, Clinical IT, and Bioresearch Quality & compliance (BRQC). Your primary responsibilities will include leading operational aspects of clinical studies, ensuring compliance with ICH GCP guidelines, company SOPs, and local regulations. You will serve as the point of contact for local projects funded by India R&D, participate in pipeline planning, and mentor junior team members globally. Additionally, you will oversee the selection and evaluation of external service providers, train site personnel, identify quality risks, and develop corrective action plans as needed. Furthermore, you will be responsible for preparing or reviewing essential study documents, overseeing the preparation and release of investigational products, ensuring sponsor oversight, reporting adverse events, maintaining the Trial Master File, coordinating clinical trial disclosures, and writing/reviewing Clinical Study Reports. Your role will also involve providing administrative and technical support to junior Study Managers and aiding in site activation activities. To be successful in this role, you should possess a Bachelor's Degree in a scientific discipline or health care, with a minimum of 7 years of prior clinical study management experience, including at least 2 years in a people/team management capacity. You should have in-depth knowledge of global clinical research regulatory requirements, electronic trial master file management, and clinical trial management systems. Strong leadership, communication, organizational, and problem-solving skills are essential, along with proficiency in Microsoft Word, Excel, and PowerPoint. In return, Kenvue offers a competitive Total Rewards Package*, including paid company holidays, vacation, learning & development opportunities, and employee resource groups. The specific salary range and benefits will be discussed during the recruitment & hiring process. Join us at Kenvue in shaping the future and impacting the lives of millions of people every day through your work as a Manager, Clinical Operations in Bangalore, India.,

As a Study Country Lead at AstraZeneca, you will have the overall responsibility for the study commitments within the country and ensure timely delivery of data to the required quality. Leading the Local Study Team, you will work together with various stakeholders to optimize team performance and ensure compliance with AZ Procedural Documents, ICH-GCP, and local regulations. Your role will involve leading the site selection process, overseeing the submission of applications to EC/IRB and Regulatory Authority, preparing study budgets, and maintaining accurate financial records. You will be responsible for coordinating local drug activities, setting up and maintaining the study in CTMS, and managing monitoring activities from site activation through study closure. In addition, you will play a key role in identifying risks, resolving complex study problems, and proactively communicating study progress, risks, and mitigation plans to the Global Study Associate Director/ Global Study Team. Your contribution to patient recruitment strategy, risk management plan development, and participation in audits and regulatory inspections will be crucial to the success of the study. Collaboration with the local Medical Affairs team, ensuring compliance with AstraZeneca's Code of Ethics, and providing regular updates to Line Managers on study milestones are also significant aspects of this role. Your feedback on research-related information and compliance with local policies and code of ethics will further contribute to the success of the study. To excel in this role, you should have a Bachelor's degree in a relevant discipline, significant experience in Study Management within a pharmaceutical or clinical background, and thorough knowledge of Patient Safety processes and local regulations. Advanced degrees, professional certifications, clinical study delivery operational experience, and project management experience will be considered advantageous. Join us at AstraZeneca, where we are dedicated to being a Great Place to Work, empowering you to push the boundaries of science and unleash your entrepreneurial spirit. We are committed to building an inclusive and diverse team, welcoming applications from all qualified candidates, regardless of their characteristics. Embrace diversity, equality of opportunity, and join us on an exciting journey to pioneer the future of healthcare.,

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits