Snr Lab Project Set-up Coord

4 days ago

Mumbai, India Q² Solutions Full time

Job Overview
Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration.

Essential Functions
- Assist with study validation activities
- Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements
- Configure project database, where applicable
- Maintain accurate project documentation files
- Keep Setup Managers, Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project
- Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings)
- Participate in local and global improvement projects as defined by the relevant process improvement management team
- Participate in internal audits, as required
- Communicate with study Sponsor(s) as needed (e.g. exchanging factual information)
- Assist in the development of database design requirements for protocols and protocol amendments
- Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues
- Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

**Qualifications**:

- High School Diploma or equivalent Req And
- Bachelor's Degree Life Sciences or related field Pref
- Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry.
- r equivalent combination of education, training and experience.
- Posses strong organizational and coordination skills.
- Proven track record of quality, accuracy and attention to detail.
- Good written and verbal communication skills including good command of English language.
- Posses enhanced technical and operational knowledge, especially in the area of Clinical Trial Management Systems (preferred).
- Demonstrated ability to work in a fast-paced environment.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Knowledge of Laboratory processes and computer systems helpful.

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