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Clinical Data Manager III

4 months ago

Chennai, India Allucent Full time

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for Clinical Data Manager III (CDM III) to join our A-team (hybrid*). As CDM III at Allucent, you will manage and coordinate DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

PLEASE NOTE: This is not a remote position and we are looking for a candidate who can work from the office (Chennai Location).

In this role your key tasks will include:

Lead and serve as primary contact for DM with all relevant parties both internally ( Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally ( sponsors, vendors (EDC, external data), and investigational sites) Plan and project the resources required including management of tasks, timelines, risk and quality Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements Participate in the review of study documents ( protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks Create training materials for EDC users and provide project-specific training as required Review and validate clinical data to ensure consistency, accuracy, integrity and completeness Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)  Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance  Support and conduct Quality Review checks during study. As lead DM, may organize and lead Quality Review activities Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)  Manage the database maintenance, lock and close-out processes and procedure  Participate in conference calls and/or meetings with vendors and sponsors  Recognize and solve potential problems and evaluate effectiveness  Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned  Help to align data management and clinical programming best practices, standards and conventions within the company  Propose and support initiatives for improving efficiency.

Requirements

To be successful you will possess:

Minimum Educational Requirement: Preferably Life science graduate or equivalent qualification6+ years’ experience in clinical data management experience within Contract Research Organization (CRO), Pharmaceutical or biotech industries Proven knowledge of clinical data management processes 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-paced growing organization. Demonstrated ability to work in a global team environment. Demonstrates a 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.

Benefits

Benefits of working at Allucent include:

Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”