Pharm-Olam International Data Manager in Bangalore, India
About Pharm-Olam International:
Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.
Job holder is accountable for the quality of work performed.
Responsible for effectively participating in the start-up and completion of multiple Data Management projects according to Sponsor and contract requirements and in accordance with applicable standard operating procedures.
May be a study lead for Data Project Manager (DPM) and liaise as appropriate with Sponsor and project team on key issues and progress updates.
Effective supervision of all data management aspects of assigned project(s) from setup to lock.
Attend regular meetings with the Sponsor and project team, for discussions relating to data management issues and provides status updates for the project with guidance from DPM.
Report on quality and performance metrics, including timelines, to DPM and, if required, Management.
Participate in in-house and external training courses, where required.
Work in strict adherence to SOPs as well as current ICH-GCP guidelines and other applicable standards required by Regulatory Authorities.
Participate in the preparation/review of Data Management process control documents, including but not limited to Data Management Plan, Data Quality Checks Specification, User Acceptance Testing and Data Transfer Agreements/Specifications, reconciliation plans, data review & quality plans.
May review database validation documentation and approve deployment in conjunction with Data Systems and DPM.
Coordinate and manage training for investigators, coordinators, data entry and CRAs on using the selected applications for data entry and cleaning, as applicable to study parameters.
Review, freeze and/or lock data in accordance with DM control documents for accuracy, completeness, consistency and validity, generate queries as necessary to sites, as well as project team.
Perform ongoing quality control and data review.
Participate in the production/coordination of reports and listings for team reviews and DSMBs (Data Safety Monitoring Boards).
Coordinate with Medical Data Reviewer and/or Medical Monitor for the coding of medical terminology, as required.
Participate in development and finalization of any third party transfer specifications for electronic database load both to and from Pharm-Olam.
Maintain Data Management study documentation on ePOI in an ‘audit-ready’ status, including periodic QC of documentation versioning, approvals and appropriateness.
Perform reconciliation, including but not limited to SAS/AE, Electronic Data Files (EDF) and third party data such as central labs and IVR, against the clinical database and track issues to resolution.
Provide DPM with status updates and any issues/risks to deliverables to ensure the project team and Sponsors’ are kept informed of all issues and quality performance achieved.
May present at investigator meetings and PM/CRA training sessions.
Identifies and recommends process improvements to management team, as identified.
Direct reporting line to Manager, Data Management, with functional reporting line to ADPM or others as appropriate.
Collaborate with DPM, Pharm-Olam DMs and project team members.
Collaborate with Data Systems Team, SAS Programmers, Statisticians and Medical Writers (internal and/or external).
Collaborate with Data Entry staff and study CRA’s.
Support site investigators and study coordinators with regard to EDC training, problems and query resolution.
Data Manager Grade I:
Preferably a minimum of a Bachelor's degree in a Life Science, Nursing, Computer Science or related discipline.
3-5years experience in clinical data management.
Experience within the CRO industry.
Proven knowledge of clinical data management process and clinical database systems, including Electronic Data Capture applications.
Good communication skills: written and verbal.
Effective working knowledge of Microsoft Office Suite including Word and Excel.
Demonstrated problem solving, analytical, organizational and time management skills
Demonstrated flexibility and ability to work well in a team environment.
Full knowledge of clinical data flow and research design.
Demonstrated ability to be compliant with ICH-GCP/regional regulatory guidelines and POI SOPs.
Comprehension of study documentation standards including Trial Master File organization and archival processes.
Awareness of data standards, preferably CDISC STDM.
Data Manager Grade II:
As per Data Manager I requirements.
Previous experience at Data Manager Grade I level (or equivalent).
Work independently to meet study deliverables.
Lead mid-size global trials from startup to final end of study deliverables.
Data Manager Grade III:
As per Data Manager I and II requirements.
Previous experience at Data Manager Grade II level (or equivalent).
Successfully meet study deliverables and exceeds sponsor expectations.
Manage study resources, including Data Manager I/II team members.
Ability to manage multiple mid to large-size global trials from startup to final end of study deliverables.
Due to the number of inquiries, we are unable to respond to each inquiry. Candidates of interest, matching the above qualifications will be contacted for further consideration.
PRINCIPALS ONLY, NO PHONE CALLS PLEASE.
External Company URL: www.pharm-olam.com
Street: No. 15, KMJ Arcadia