Clinical Data Team Manager Job in Unikaihatsu Software Private Limited
Clinical Data Team Manager
Unikaihatsu Software Private Limited
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
Job Summary
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 recruitbpo@usindia.com Sub Line REQ 2019 Q4 R144 Ref: (usindia)
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 recruitbpo@usindia.com Sub Line REQ 2019 Q4 R144 Ref: (usindia)
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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