About the role
Primary Responsibilities:
- To prepare, review and maintain Standard Operating Procedure, Work Instructions and policies in line with the requirements defined as per standards, guidelines, industry trends and internal policies.
- To provide support for audits (regulatory, certification, client and vendor audits).
- Review of ClinChoice Global documents such as risk tracker, non-conformity forms etc.
- To analyze root causes and review/propose CAPAs/corrections.
- Identify areas of risk in liaison with operations team and develop risk mitigation program.
- Coordinate for system implementation/improvement of QMS related activities for all support functions.
- Ensure data security/privacy measures are implemented/ managed in the relevant delivery teams by providing trainings to the delivery leads and the team members.
- Participate in Management Review Meetings and follow up for the compliance of decisions made.
- Participate and implement system upgrades as per management requirement.
- To take up further responsibilities as assigned by reporting manager or management.
Secondary Responsibilities:
- To serve as back up for all quality related functions or take up secondary responsibility as per requirement and training provided.
- Support in quality metrics management for projects.
- Review and analyze organizational level metrics as well as project engagement level metrics where applicable.
QMS/ ISMS/ PIMS Responsibilities:
- Be aware of and comply with the QMS/ ISMS & PIMS Policy.
- Participate and contribute to data protection impact assessments, risk assessments as applicable.
- Report any potential or actual security breaches to the regional and/or global DPO & security incidents to CISO/ applicable distribution list.
- Contribute towards achievement of Quality Objectives including QMS, ISMS and PIMS.
- To take up any further responsibilities as assigned by reporting manager or Management as per training provided.
Skills and Qualifications:
- Bachelor's/Master's degree in Life Sciences or equivalent
- With at least 2 years relevant experience.
Aplyr's read
ClinChoice is a dynamic global CRO catering to the pharmaceutical and biotech sectors, attracting professionals skilled in regulatory affairs, biostatistics, and clinical programming.
What's promising
- •ClinChoice offers a diverse range of roles in clinical research, appealing to specialists in biostatistics and regulatory affairs.
- •The company provides opportunities for remote and hybrid work, offering flexibility to its workforce.
- •ClinChoice's global presence allows employees to engage with international projects and clients.
What to watch
- •Limited public information about ClinChoice's workplace culture and employee satisfaction.
- •The company may face competition from larger CROs with more established reputations.
- •Potential candidates might find limited career advancement information publicly available.
Why ClinChoice
- •ClinChoice focuses on comprehensive services across pharmaceuticals, biotechnology, and medical devices.
- •The company has a strong emphasis on statistical programming and regulatory affairs roles.
- •ClinChoice's recent hiring trends show a commitment to remote and hybrid work models.
Aplyr’s read is generated by AI from public sources. Was it useful?
About ClinChoice
ClinChoice is a global clinical research organization (CRO) that provides comprehensive services to the pharmaceutical, biotechnology, and medical device industries.
