4 Study Design Jobs

The main purpose of your role as an experienced professional individual contributor in Medical Affairs is to work under limited supervision and apply your subject matter knowledge effectively. Your capacity to apply skills and knowledge should meet specific needs or requirements within the field. As an experienced professional in the Medical Affairs Sub-Function, you will be responsible for overseeing the direction, planning, and execution of clinical trials and research activities. You will play a key role in data collection, implementation of clinical protocols, and ensuring completion of final reports. Additionally, you will be involved in recruiting clinical investigators, negotiating study designs and costs, and directing human clinical trials, specifically phases III & IV for company products under development. Your responsibilities will also include participating in adverse event reporting, safety responsibilities monitoring, coordinating reporting information for submissions to regulatory agencies, monitoring adherence to protocols, and determining study completion. Furthermore, you will coordinate and oversee investigator initiations and group studies. You may also act as a consultant or liaison with other corporations when working under licensing agreements. In terms of education, you are required to have an Associates Degree (13 years), and a minimum of 1 year of relevant experience in the field. Your role demands a high level of professionalism, attention to detail, and the ability to work effectively within a team environment to achieve the goals of the Medical Affairs Sub-Function.,

As a Biostatistics Manager at our organization, you will play a pivotal role in managing and supervising a team of statisticians and biostatisticians. Your responsibilities will include overseeing statistical analysis and reporting activities for clinical trials, providing guidance on study design, sample size estimation, and statistical methodologies, as well as collaborating with cross-functional teams to ensure timely and accurate deliverables while maintaining compliance with regulatory guidelines and industry standards. In this role, you will be required to manage and allocate resources within the biostatistics team, ensuring adherence to quality and regulatory standards in statistical analysis. You will also collaborate with project teams to develop statistical analysis plans, oversee the preparation of statistical deliverables for regulatory submissions, provide guidance on complex statistical issues and study interpretations, and foster a culture of continuous learning and professional development within the team. To qualify for this position, you should have a Master's degree or Ph.D. in Statistics, Biostatistics, or a related field, along with a minimum of 8-10 years of progressive experience in Biostatistics, including leadership roles, within the pharmaceutical, biotechnology, or CRO industry. You should possess extensive experience in statistical analysis and clinical trial research, strong leadership and management skills, excellent communication and presentation abilities, and the ability to collaborate effectively with cross-functional teams. Join us in our mission to make work meaningful together, where alternative thinking gives rise to innovative ideas and human-centric processes are created through teamwork, co-creation, and co-execution. At YouV, you can expect unparalleled exposure, valuable learning opportunities, and a positive work environment that will add great value to your career. Immerse yourself in our unique culture of warmth and positivity, where collaboration, open-door policies, and inclusivity are at the core of everything we do.,

Position Overview: We are seeking a highly qualified and experienced Director Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology, and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: o Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. o Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. o Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: o Oversee the planning, initiation, execution, and close-out of clinical trials. o Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. o Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: o Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. o Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: o Collaborate with biostatisticians and data managers to analyze clinical data. o Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: o Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. o Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: o Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: o Minimum 5-10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. o Prior experience in oncology research is highly preferred. o Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: o Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. o Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. o Strong communication, leadership, and problem-solving skills. o Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad