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Pharmacovigilance Reviewer

Clinical Data – Team Manager

  • Clinical Data – Team Manager

    Position Clinical Data – Team Manager
    Reporting to General Manager
    Qualifications / Work Experience Formal Education
    • Graduate, preferably in science
    • Bachelor’s degree / Masters in Life sciences,
    • MBBS/BHMS/ BAMS/ BDS/ Paramedical degrees,
    • B. Pharm/ M. Pharm
    • Bachelors / Masters in Clinical research
    Certifications
    • Certifications / Diploma in IT &/ CDM
    Work Experience
    • Previous experience as a Biometrician/ Senior Biometrician 3 – 4 years.
    Candidate having equivalent qualifications, training & experience may be considered.
    Essential Competencies (Knowledge, Skills and Attributes) Expected Competency Domain
    • Good technical knowledge of medical terminology.
    • Compliant with GCP/GCDMP.
    • Computer and Internet skills and experience (familiarity and comfort with MS Office products).
    • Understanding database/programming concepts.
    • Able to use SQL and other programming/query languages.
    • Oral and written English communication skills.
    • Self-motivated and enthusiastic.
    • Ability to develop and deliver presentations.
    • Knowledge of clinical trial principles, methodology and procedures.
    • Knowledge of all federal, state regulations and guidelines pertaining to the conduct of clinical trials on human subjects.
    • Knowledge of current and developing trend and standards in clinical trials monitoring.
    • Ability to independently develop novel concepts and techniques in Data management techniques.
    • Ability to establish and maintain effective working relationships with co-workers, managers and clients.
    • Experience in effectively managing multiple tasks simultaneously.
    • Effective problem solving skills is a position requirement.
    Accountability Domain
    • Good technical knowledge of the process of CDMS (e.g. Clintrial, Oracle Clinical).
    • Understand and comply with Standard Operating Procedures.
    • Anticipate problems, issues, and proactively work to minimize the impact.
    • Maintenance of strict confidentiality in all CAC-India projects.
    • Is accountable for achieving deliverables for a project meeting timelines & quality standards required.
    • Ensures high performance and efficiency of the team through ongoing mentoring of DM team.
    Key Responsibilities: Clinical Data Processing
    • Provide study status reports to head of the department.
    • Maintain current knowledge of company standard operating procedure (SOP) and participate in development and review of all SOPs.
    • Perform all duties and responsibilities in accordance with GCP guidelines, regulations, statutes and SOPs.
    • Establish appropriate Data Management tools and processes for the study team.
    • Work collaboratively with other functional groups (Clinical Operations, pharmacovigilance, quality assurance, biostatistics) in the organizations within the trials.
    • Provide ongoing training and support to the Data Management team through establishment of study tools and training materials, frequent team meetings, and regular communication.
    • Identify quality issues during the study through regular review of the Data Management team communications & institute appropriate corrective action plans.
    • Communicate and establish a customer service relationship with the clinical client representative as appropriate.
    • Define resource requirements and work with supervisor to prioritize resource assignments across projects.
    • Provides review and guidance for production of Data Management documentation or deliverables that are produced by the Data Management Function.
    • Provides technical advice and solutions with internal and external customers to solve problems and improve efficiency.
    • The position is required to participate in the implementation of new processes and technology.
    • Ensures that staff is trained and compliant with current operating procedures and work instructions and project scope of work.
    • Identification of professional development/training needs of staff are required to be addressed by the Manager.
    • Mentoring staff members to develop Data Management process and system expertise is a requirement of the position.
    • Primary customer interactions at project level with a focus on specific Data Management Function with established customers provide operational input into proposals and scope of work is a position expectation.
    • May participate in customer meetings and lead discussions of project requirements and strategic planning.
    • Understand scope of work, budget, and scope assumptions.
    • Identify out of scope work and contribute to estimating costs of this work.
    • Ensuring project milestones pertaining to Data Management Function are met according to agree upon timelines with high quality is a position expectation.
    • May spend significant time performing work tasks associated with Data Management Function, typically in a lead role.
    • Manage delivery of projects through full data management study life-cycle (with minimal guidance).
    • With guidance from Manager, manage project timelines and quality; determine resource needs; identify out-of scope work.
    • Perform database designer activities for technologies not requiring extensive programming.
    • Perform comprehensive quality control procedures.
    • Assist in developing and implementing new technology.
    • Meet objectives as assigned.
    Additional Information Industry type
    • Pharma/ Biotech/ Clinical research
    Functional Area
    • Life science
    Experience
    • 6 to 8 years of Experience
    Location Mumbai
    Working Hours As per company policy or depending on Project requirement
    Travel Not Required
    Job Code R144
    E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.
    Sub Line REQ 2019 Q4 R144 Ref: (usindia)

Pharmacovigilance Coordinator

Clinical Data Reviewer / Validator

Clinical Data Coordinator