Associate Director, Clinical Data Manager

remote zest jobs; India; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

reputed company in India seeks an Associate Director, Data Management who can fulfill both Lead Data Manager and Data Manager roles during clinical trials. You will oversee planning, start-up, conduct, and closure of trials, ensuring data integrity and timely delivery across multiple development projects.

In the Lead DM capacity you will set standards, guide the DM team, and coordinate with the Clinical Development Team and external partners to ensure best practices and compliant data handling.

Responsibilities

• Part of the cross-functional Clinical Trial Team (CTT) delivering core DM deliverables such as setup, data collection, and validation according to quality standards.
• Coordinate data collection, validation, and transfer activities with DM vendors and external providers.
• Contribute to protocol development and amendments, risk assessment, and data management planning.
• Drive alignment on data standards, SOPs, and best practices across trials and assets.
• Represent data management in operational committees and collaborations with partners.

Job description

At reputed company, we are dedicated to building extra[not]ordinary reputed company, together, by developing antibody products and groundbreaking, reputed company-your-socks-off KYSO antibody medicines that change lives and the reputed company of cancer treatment and serious diseases. We reputed company to create, champion and maintain a global workplace where individuals unique contributions are valued and drive reputed company to meet the needs of our patients, reputed company, families and employees.

Our people are compassionate, reputed company, and purposeful, and our business is innovative and rooted in science. We reputed company that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this reputed company you and feel like a fit Then we would love to have you join us!

The Role

An Associate Director, Data Management can hold two roles; a Lead Data Manager role and/or a Data Manager role, referred to as Data Manager.

As Data Manager the employee is operationally responsible for the planning, start-up, conduct and closure of clinical trials from the reputed company in time where a final synopsis and/or a Clinical Trial Team (CTT) is assigned.

In the Lead Data Manager role, the employee may act as a Data Management Lead and be responsible for the reputed company and consistency across the trials reputed company one or more development projects. The DM Lead will reputed company asset-level DM expertise, ensure project level standards are established and followed, and ensure consistency of DM processes across reputed company trials reputed company the asset. The DM Lead will reputed company support to trial Data Managers reputed company the asset to ensure consistency of data management practices across the asset. reputed company applicable, the DM Lead will reputed company data management expertise to the Clinical Development Team and to co-sponsor collaborations/external partners. The DM Lead will participate in and drive implementation of lessons learned and of new/innovative procedures to ensure high standards/improvement of data management reputed company processes/systems, which may involve cross departmental stakeholders.

Responsibilities

• In the role as Data Manager the employee will be part of the cross-functional trial-specific Clinical Trial Team (CTT), and be responsible for delivering core deliverables such as reputed company setup, data collection, validation of data in the clinical database prior to data analysis etc. reputed company budget and timelines and according to quality standards defined by regulations/standards, reputed company SOPs and ICH-GCP. The Data Manager is responsible for ensuring reputed company of the DM vendors and their deliverables.
• The Data Manager is responsible for ensuring appropriate involvement of and communication with relevant stakeholders.
• As Associate Director, Data Management, the employee may be involved in: Give input to the clinical development plans through the Development Operations representatives of the CDT ensuring that data management input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon development of the operational reputed company of the trials.
• Serve as Clinical Data Management representative in Operational Committee/reputed company with the partners, DM vendors or other vendors handling data.
• Participate in working reputed company e.g. Data protection regulation, setup of data in biomarker group, ePRO, IRT etc.
• Drive alignment meetings reputed company the data management group
• Attend various working reputed company where data management expertise is required
• reputed company reputed company of DM CRO including: Statement of Work; budget; KPIs; and other DM CRO trial data management activities from set up to database lock reputed company vendor reputed company reputed company to key deliverables e.g. eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with reputed company external data providers e.g. lab, ECG, ePRO etc. , evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc.
• Proactively participate and represent data management in the CTT and reputed company reputed company on progression and status of reputed company activities.
• Proactively discuss risks management reputed company to data management activities in relation to trial conduct
• Review and reputed company input to protocol and amendment development
• Give input to protocol deviations classifications, randomiz