Clinical Data Manager

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.

We are growing our operations in India, with remote working opportunities as well as career openings in our Bangalore, Pondicherry and Mysore locations.

Primary Responsibilities

Ensures clinical trial databases meet project requirements by:

• Overseeing all data management deliverables for assigned studies

• Reviewing documentation and requirements for new projects and anticipating impact to Data Management (DM) standards/processes

• Collaborating with appropriate project teams as needed to stay abreast of and changes that could affect data collection, cleaning and/or transfers

• Attending and participating in client meetings as requested

Ensures the plan for data management is properly executed by:

• Understanding the requirements for study implementation and data collection

• Collaborating with project team to develop study-specific edit check criteria

• Evaluating the standard edit checks and recommending modifications where necessary

• Maintaining organized, complete, and up-to-date study documentation

• Developing and tracking timelines and ensuring CDM project milestones are met in coordination with the project team

• Leading study setup, including TF design, database structure, specification, and obtaining and providing approvals as needed

• Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors)

• Creating and maintaining the Data Management Plan when required

• Keeping supervisor informed of project status

Ensures the accuracy and consistency of clinical databases by:

• Reviewing data and identifying errors/inconsistencies

• Collaborating with appropriate project team to resolve data issues

• Tracking outstanding issues and following-up until resolution

• Preparing and validating ad hoc data listings as necessary

• Ensuring that system bugs and needs for enhancement are reported to CDM Management and the applicable Engineering Product Manager, and that any stop-gap CDM programming is approved

• Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines.

Mentors team members, if applicable, by

• Training team member on departmental processes and documentation methods

• Assisting team member with problem solving and troubleshooting issues

• Leading by example with professional and collaborative conduct

• Answering questions and proposing technical solutions specific to data management processes

• Delegating appropriate and challenging assignments to Clinical Data Manager to encourage growth, development and interdependence

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

• Adhering to all BioClinica Clinical Data Management (CDM) procedures, policies, and work instructions

• Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)

• Assisting in establishing and enforcing departmental standards

• Participating in the review and updating of company SOPs related to DM Services

• Working with CDM management to discuss and seek resolution to department issues

Contributes to team effort by

• Working with internal staff to resolve issues

• Exploring new opportunities to add value to the organization

• Helping others to achieve results

• Performing other duties as assigned

• Participating in assigned departmental initiatives, including SOP development

• Participating in training and coaching new hires on departmental processes and tasks

• Participating in designing and creating new tools to help improve the department processes

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

EEO Statement

Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.