Data Manager (Expert in Programming & developing EDC systems)

SmartRecruiters, Inc.; Pune District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Ergomed Group is seeking a Data Manager within its Data Management team to oversee database testing, query management, lab reference ranges, SAE reconciliation, and vendor data reconciliation. The role reports to the Manager, Data Management and works under the Project Data Manager on project level.

You will support DM and EDC activities from protocol initiation through database lock, including data cleaning, study start-up, conduct, and close-out tasks.

Qualifications

• Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline.
• 4-8 years of relevant clinical data management experience in pharmaceutical industry and/or CRO and/or similar data management experience.

Responsibilities

• Study start-up: Validate EDC systems and DM reports/listings.
• Validate EDC and SAS edit checks.
• Manage and create EDC user accounts.
• Update and maintain DM documentation per Lead Data Manager.
• Contribute to database specifications, build and UAT during development.
• Study Conduct: Enter data from trial documents into data entry systems.
• May perform Medical Coding and manage lab reference ranges.
• Attend internal/external teleconferences and review study metrics.
• Escalate roadblocks and provide status updates to the team.
• Study Closure: Support DM close-out activities and DBL checklists.

Skills

Data management

EDC systems

SAS edit checks

Lab reference ranges

Education

Bachelor's degree

Job description

• Full-time
• Department: Data Management

Company Description

Medicine moves forward here. So will you.

Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.

The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.

Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.

Job Description

The Data Manager within the ERGOMED Data Management (DM) is responsible for database testing, query management, management of lab reference ranges, serious adverse event reconciliation, vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager, Data Management and is supervised by the Project Data Manager on a project level.

The Data Manager is responsible for supporting various data management and EDC activities from initiation of protocol through database lock data cleaning activities including:

Study start-up

• Perform validation of EDC Systems and associated DM reports or listings
• Perform validation of EDC and SAS edit checks
• Manage and Create EDC user accounts
• Update and maintain DM documentation as directed by the Lead Data Manager (LDM) orProject
• Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development

Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)

• May enter Data from trial documents into data entry system
• May perform Medical Coding
• Manage the entry, review, and tracking of Local/Central Lab reference ranges
• Attend internal/external teleconferences as needed
• May create and review study metric reports for internal/external project teams
• Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
• Provide the PDM with status updates on tasks that are assigned
• Escalates significant issues promptly to the study team

Study Closure

• Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution, final reconciliations, development of reports)

Qualifications

Bachelor's Degree, preferably in Live Sciences, Computer Science, or other related scientific discipline

• 4-8years of relevant clinical data management experience in pharmaceutical industry and/or contract research organization and/or similar data management experience in a non-clinical environment

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.

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