clinical data manager III in Allucent (PharmOlam)

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CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies

Job Title: Data Manager (Level III)

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• May serve as the Lead Data Manager (client facing role) on assigned projects.

• Effective management of all data management aspects of assigned project (s) from set up to database 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 Data Project Manager/Oversight Director.

• 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, Data Transfer Agreements/Specifications, Reconciliation plans, CRF Completion Guidelines, etc.

• Coordinate and manage training and EDC access for investigators, coordinators, data entry and CRAs on selected applications for data entry, cleaning, and running reports, as applicable to study parameters.

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• Review, freeze and/or lock data in accordance with Data Management documents for accuracy, completeness, consistency and validity, generate queries, as necessary, for sites and/or project team.

• Perform ongoing quality control and data review.

• Participate in eTMF audits as necessary. Respond to auditors’ comments in a timely fashion.

• Participate in the production/coordination of reports and listings for team reviews, Interim Analysis, and/or DSMBs (Data Safety Monitoring Boards), as specified in contract with client.

• 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 Allucent.

• Maintain Data Management study documentation on sharepoint in an ‘audit-ready’ status, including periodic QC of documentation versioning, approvals, and appropriateness.

• Participate in responding to QC comment in a timely manner in conjunction with Data Project Manager/Oversight Director.

• 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 Data Project Manager/Oversight Director, 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.

• Co-ordinate and collaborate with internal and external stakeholders.

• Is aware of study budget and identifies OOS tasks.

• Is able to execute quality tasks with minimal supervision.

• Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification

• 5+ years’ experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries

• 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 proactiveness, problem solving, analytical, organizational and time management skills.

• Demonstrated flexibility and ability to work well in a fast faced growing organization.

• Demonstrated ability to work in a global team environment.

• Demonstrates basic understanding of Clinical Trials and the flow of data.

• 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.

• Familiarization of data standards, preferably CDISC STDM.

• * An office based role(Chennai/Bangalore India)

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