Company Information
At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.
Company Culture
Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.
Job Duties & Responsibilities
- Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol.
- Design and develop case report forms for clinical trial study protocols
- Develop a familiarity with Advarra's Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.
- Work closely with reporting manager to complete daily/ weekly calendars and/or case report forms design to meet with pre-determined quality criteria
- Participate in customer interactions over the e-mail to assimilate customer requirements and address those adequately in the design and development of calendars and case report forms
- Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked
- Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols
- Monitor the team performance, timeliness and quality
- Work with Managers to help manage performance management of their team
- Work with the QC team to understand learning gaps for their team and develop a learning plan
- Manage communication with customers
Location
This role is open to candidates working hybrid in Bengaluru, India.
Basic Qualifications
- Graduate-Life Sciences, BCA, MCA, BE- Biotech or equivalent experience
- 6+ years work experience in job areas such as:
- Clinical data management
- Clinical trial coordination at site
- Pharmacovigilance
- Clinical research associate
- Records management
- Sound knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research
- Expected to work independently, as well as in a team environment
- Excellent organizational and administrative abilities
- Ability to liaise with key stakeholders across the organization
- Familiarity with MS Office and various business software
Preferred Qualifications
- Highly personable nature that fosters teamwork
- Excellent communication skills oral as well as written
- High energy and positive attitude towards working in a culturally diverse environment
- A passion for ensuring outstanding customer support with a solutions-oriented attitude.
- Proactive and takes ownership in all tasks from start-to-finish.
Physical and Mental Requirements
- Sit or stand for extended periods of time at stationary workstation
- Regularly carry, raise, and lower objects of up to 10 Lbs.
- Learn and comprehend basic instructions
- Focus and attention to tasks and responsibilities
- Verbal communication; listening and understanding, responding, and speaking
Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.
