Antara Senior Care - Manager - Clinical Affairs

Role Summary:

- As a Clinical Affairs Specialist for D2C Healthcare New Products at AGEasy by Antara, you will play a critical role in leading the planning, execution, and management of clinical studies and trials for our direct-to-consumer healthcare products. Your responsibilities will include developing and implementing clinical research strategies, collaborating with internal and external stakeholders, overseeing patient recruitment and monitoring processes, analyzing clinical data, and ensuring compliance with regulatory standards and ethical guidelines.

- You will be instrumental in evaluating the safety, efficacy, and performance outcomes of our new products through rigorous clinical research, and your findings will help support product registration, commercialization, and the development of evidence-based marketing materials. Your expertise in clinical affairs, regulatory requirements, and data analysis will contribute to the successful advancement of our healthcare solutions for consumers seeking improved health and well-being

Responsibilities:

- Lead the planning, execution, and management of clinical studies and trials for direct-to-consumer (D2C) healthcare new products at AGEasy by Antara.

- Develop and implement clinical research strategies, protocols, and timelines in alignment with regulatory requirements and business objectives.

- Collaborate with internal teams, external partners, and clinical investigators to ensure the successful implementation of clinical studies.

- Oversee patient recruitment, enrollment, and monitoring processes to ensure study timelines and objectives are met.

- Collect, analyze, and interpret clinical data to evaluate product safety, efficacy, and performance outcomes.

- Prepare and review study reports, publications, and regulatory submissions to support product registration and commercialization.

- Maintain compliance with ethical standards, Good Clinical Practice (GCP), and relevant regulatory guidelines throughout the clinical research process.

- Act as a liaison between the clinical affairs team, regulatory authorities, and other stakeholders to address queries and ensure study integrity.

- Stay informed about industry trends, advancements in clinical research methodologies, and changes in regulatory landscape related to D2C healthcare products.

- Contribute to the development of evidence-based marketing materials, educational content, and product training programs based on clinical study findings.

Qualifications:

- Bachelor's or Master's degree in Life Sciences, Clinical Research, or related field.

- Minimum of 3-5 years of experience in clinical affairs, clinical research, or related roles within the healthcare industry.

- Proficiency in designing and managing clinical studies, including protocol development, data collection, and analysis.

- Knowledge of regulatory requirements, GCP guidelines, and ethical considerations in clinical research.

- Strong communication, organizational, and project management skills.

- Ability to work effectively in a cross-functional team environment and collaborate with internal and external stakeholders.

- Experience with direct-to-consumer healthcare products or services is a plus.

- Commitment to upholding the highest standards of clinical research integrity and patient safety.