CTA-ClinOps

JOB DESCRIPTION

Job Title: CTA-ClinOps

Job Location: Bangalore

Department: CLINICAL OPERATIONS T&CR

About Syngene: Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures practices and systems that ensures safe operations and compliance to companys integrity & quality standards
• Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self teams and lab/plant by adhering to safety protocols and following environment health and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrityhealth and safety measures are completed on time by all members of the team including self
• Compliance to Syngene s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

• Assist Clinical Study Manager (CSM) and Clinical Research Associates (all levels) by accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
• Assist the clinical team in the preparation handling distribution filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
• Assist CSM and CRA (all levels) with preparation handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs) queries and clinical data flow.
• Act as a central contact for the study team for designated project communications correspondence and associated documentation.
• Perform assigned administrative tasks to support team members with clinical trial execution.
• Coordinate with Quality Assurance in providing TMFs (Trial Master File) (In-house) during the In-house Audit.
• Secondary contact between site external vendors internal team members and cross-departments for study level activities
• Co-ordinate with the translation agency for getting relevant study documents translated and back-translated as required for the study
• Timely submission of timesheets for project-specific and other tasks

Role Accountabilities:

1. Document Management to ensure timely filing and keep all study documents for any time audit and inspection readiness:

• Maintain and update the Trial Master File (TMF) and/or Investigator Site Files (ISF)
• Ensure proper filing tracking and archiving of clinical documents (e.g. protocols informed consent forms approvals)
• Perform quality checks on trial documents for completeness and accuracy.

1. Support the team in timely regulatory & ethics committee submission and maintain their records.

• Assist with preparation and submission of documents to regulatory authorities and ethics committees
• Track regulatory approvals and study start-up milestones

1. Clinical Trial Coordination

• Support CRA and CSMs in planning and tracking clinical trial activities
• Assist in scheduling investigator meetings site initiation visits monitoring visits and close-out visits

1. Communication & Liaison

• Act as a communication hub between internal teams (e.g. CRAs CSM and other cross functional team like data managers as applicable) and external stakeholders (e.g. sites vendors)
• Distribute study-related communications and updates to sites and team members

1. Support senior leadership and CSM to extract and maintain study status reports (eg: Data Entry & Tracking timely filing Protocol deviations)

• Enter and track data in clinical trial management systems (CTMS)
• Maintain logs such as site contact lists screening/enrollment logs essential document trackers

1. Trial Supply Management

• Support CRA and CSM to coordinate shipment of study supplies and investigational product (IP) to sites and maintain their in-house documentation.
• Track inventory and reconcile supplies with site reports

1. Support During Audits & Inspections

• Prepare documentation for audits/inspections (internal or regulatory)
• Assist in responding to findings or follow-up actions

1. Training & Compliance

• Maintain training records for site and sponsor personnel
• Ensure adherence to Good Clinical Practice (GCP) standard operating procedures (SOPs) and regulatory requirements

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Looking for candidates with experience as a Clinical Research Coordinator (CRC) or other relevant experience in core clinical trial conduct.

Skills and Capabilities

• Should have good communication skills and be a good team player.
• Ability to work successfully in a dynamic ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be a focused employee.

Education: M. Sc/M. Pharm/Pharm D BAMS BDS MDS & BHMS/Any life science

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.