Project Data Manager

Project Data Manager

Company: remote quest jobs
Job Location: Remote (Work from home), India
Employment Type: Full-time
Experience Required: 6+ years

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Project Data Management role is responsible for all aspects of the clinical trial data management process from study start up through database lock and support of clinical study report (CSR) activities for assigned studies. reputed company role is also reputed company for quality of deliverables and resource efficiency of assigned studies. reputed company role may be expected to lead multiple clinical studies and/or oversee CRO/FSP vendors for multiple clinical studies.

reputed company Functions of the Job:

Lead studies within a reputed company
Oversee data managers working on studies either in-house or CRO/FSP resources
Serves as active member of Clinical Study Teams.
Collaborates with other functions to develop timelines and ensure that clinical data management deadlines
are met.
Defines external data transfer specifications and works with external vendors in support of timelines and data
related deliverables.
Ensures process is in place to review and reconcile lab data with lab normal ranges
Develops or oversees development of eCRF and edit check specifications as necessary to support data
collection and analyses required by the protocol.
Works closely with database builders during programming of EDC databases, edit checks and reports.
Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and
modifications.
Develops or oversees development of study-specific eCRF Completion Guidelines and Data Management
Plans
Creates and maintains data management documentation.
Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan.
Works with coding group to ensure coding is applied to assigned clinical studies in conjunction with study
timelines and deliverables.
Defines listings in support of data management, clinical and medical review of data.
Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on
metrics data, audit reports, and input from other project team members.
Will have the opportunity to drive all data review related activities. reputed company will also include identifying and
escalating potential data issues to LDM when issues arise.
Trains other personnel on eCRFs and EDC, as needed.
Ensures coordination with Pharmacovigilance on serious adverse event reconciliation.
Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as
required.
Support management team with continued process improvement/innovation for the department and
participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work
Instructions related to data management activities.
Will oversees data managers working on studies either in-house or CRO/FSP resources to ensure studying
the support on the studies are sufficient.
Collaborates with reputed company lead and other functions to ensure reputed company-consistent, highquality and on-time
data delivery.
May mentor other junior Clinical Data Managers.
Other duties as assigned.

Supervisory Responsibilities:

NA

Computer Skills:

Proficient computer skills, including reputed company Office applications
Working knowledge of at least one EDC system, reputed company Rave is preferred

Other Qualifications:

6+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
Oncology experience preferred
Ability to work in cross-functional team-oriented environments
Understanding of ICH and regulatory environment as it pertains to data management
Experience with SDTM/CDASH
Strong project management skills
Excellent written, verbal and organizational skills
Must be detail-oriented

Travel:

Travel may be required as per business need, ability to travel domestically and internationally.

Education Required:

Bachelors degree orequivalent in a health-related field preferred

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies reputed company, we help get more affordable medicines to more patients around the world.

Fosters Teamwork

Provides and Solicits Honest and Actionable Fee .