Senior Clinical Data Associate

Novotech; Bengaluru; In loco; INR 900.000 - 1.300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working options

Paid parental leave

Wellness programs

Ongoing development programs

Circle Back Initiative Employer

Descrizione del lavoro

Novotech is seeking a Senior Clinical Data Associate to manage day-to-day data processing for data management projects, ensuring adherence to ICH-GCP and GCDMP guidelines. You will mentor juniors, track CRF pages, validate databases, and support the DM team in a fast-paced clinical research environment.

The role reports to the Biometrics Project Manager and involves coordinating with internal teams and external providers to ensure data integrity and timely project delivery.

Competenze

• Graduate in clinical or life sciences field.
• 2–4 years of Clinical Data Associate experience in pharma or related role.

Mansioni

• Perform data management tasks including data review and query management.
• Track CRF pages and data entries; report metrics to the study team.
• Validate database specifications and edit checks procedures.
• File CRFs, DCFs, and related study documents accurately and timely.
• Mentor junior CDA staff and support data management team activities.
• Represent Data Management in meetings and audits; liaise with external providers.

Conoscenze

Data management

Data validation

Query management

Mentoring

Project coordination

Regulatory compliance

Formazione

Life sciences degree

Descrizione del lavoro

Job Description:

Responsible for day-to-day data processing operations for data management projects, including CRF (or other study data document) tracking, entry, and filing. Provides administrative and project management support to CDMs for data management projects as required, including creation and maintenance of project files. Support and mentor junior staff members. Conducts all responsible activities according to ICH-GCP and GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Responsibilities

Member of the project team reporting to the Biometrics Project Manager on projects, the Senior Clinical Data Associate is responsible for independently providing accurate data acquisition, data validation, reconciliation and mentoring the junior staff to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.

• Perform comprehensive data management tasks including data review, query management, external data reconciliation.
• Tracking of CRF pages (or other study data documents) received and entered; tracking of data queries received; proactive metric reporting of CRF pages (or other study data documents) received and entered to study team members.
• Prepare and validate database specification and edit checks specification procedures.
• Accurate and timely filing of CRFs (or other study data documents), DCFs, or other.
• DM related documents (eg. Data Management Plan, Self-Evident Corrections);
• Accurate and timely archiving of study DMF, CRF Files, and Data Query Master File.
• Perform user acceptance testing of Data Entry Screen and consistence checks of Clinical Study Databases as required.
• Mentor junior CDA staff as required.
• Represent Data Management Team on all CDA related matters, both internally and externally e.g. Investigator meetings, audits etc.
• Support CDM with CDM role activities where appropriate.
• Can act as internal DM Lead on studies, reporting to CDM/SCDM on a study level.
• Liaison with external service providers on Data Management projects as appropriate.
• Proactive participation in project meetings as requested by CDM.
• Prepare agenda/minute writing for data management team meetings; be the lead/facilitator on CDA-related topics/discussion including preparing topic presentations, and being CDA subject matter expert.
• Provide general admin and project management support to Data Management Team as required.
• Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities; awareness of other study team role procedures and how they interact/affect CDA role.
• Proactive contribution to company process improvement initiatives as required; identify opportunities for improvements with the DM Team; lead CDA related process improvements.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
• Participation in industry fora (conferences, professional associations etc) as a means.
  of professional development as well as promotion of Novotech’s image in the industry.

Minimum Qualifications & Experience

• Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered.
• At least two to four years experience working in a Clinical Data Associate (or equivalent) role in a Pharmaceutical industry or related role.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

Novotech is a global full-service clinical Contract Research Organization (CRO).

At Novotech, ambition meets opportunity. As a globally recognized leader in clinical research and scientific advisory services, we are proud to combine our position at the forefront of the industry with an award-winning workplace culture that values ambition, innovation, and growth. Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE), we are committed to fostering an environment that reflects the life-changing work we do.

Since 1997, we have expanded our global footprint, now with 30+ offices across Asia-Pacific, the United States, and Europe. This growing network unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.

At Novotech, our employees are at the heart of our success. By offering trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework, we empower team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.

With access to mentorship opportunities, professional development programs, and a dynamic community, Novotech offers a platform for driven individuals to achieve personal growth while shaping the future of healthcare. Join us to be a part of a team that values your contributions and supports your ambition to make a global impact.

At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client‑centric service model, so that our clients get a trusted, long‑term partner and an accelerated path to bring their life‑changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting‑edge of life sciences.

At Novotech you will work alongside empowered teams with a shared commitment to success.

• Strategic vs transactional mindset.
• Ability to gain insights and make proactive decisions quickly.
• Culture that fosters partnership and collaboration, where every voice is heard and valued.
• Ongoing support from senior stakeholders and leadership team.