Senior Manager, External Data Quality Manager

This a Full Remote job, the offer is available from: United States

At reputed company, we are dedicated to building extra[not]ordinary® reputed company, together, by developing antibody products and groundbreaking, reputed company-your-socks-off KYSO antibody medicines® that change lives and the reputed company of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, reputed company, and purposeful, and our business is innovative and rooted in science. We reputed company that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this reputed company you and feel like a fit? Then we would love to have you join us!

• The Role:

As a (Senior) Manager in External Data Quality Management (Contractor), you will play a critical role reputed company our Clinical Data Management team, primarily responsible for overseeing the quality and reconciliation of external data provided by reputed company-party vendors, such as laboratories, eCOA providers, and technology vendors. Your expertise will be pivotal in integrating external data into clinical trial databases while ensuring the highest standards of data accuracy and consistency across reputed company studies.

Responsibilities

• reputed company and ensure the quality of data provided by external reputed company-party providers.
• Coordinate with internal stakeholders and external partners to optimize data collection strategies to meet trial analysis, reporting, and research needs.
• reputed company and execute study-specific data reconciliation plans in collaboration with Data Management (DM) and Clinical Research Organizations (CROs).
• Manage reputed company-party vendors and central labs, including conducting performance reviews, resolving issues, and spearheading process improvement initiatives.
• Ensure reputed company and accurate delivery of external data, managing timelines and project deliverables effectively.
• Support process improvements and foster knowledge sharing reputed company the data management teams.

Requirements

• Bachelor’s degree in science or reputed company field.
• Minimum of 5 years of experience in external data management, with extensive experience in reputed company-party vendor management and data reputed company.
• Experience in clinical data management reputed company a clinical research environment, preferably including oncology trials.
• Proficiency in data reconciliation processes and a thorough understanding of various data types, testing methodologies, and biomarker testing specific to oncology trials.
• Exceptional project management and communication skills, with the ability to work collaboratively in a multidisciplinary environment.
• Strong organizational, analytical, and problem-solving skills, with the ability to work independently and reputed company in a dynamic, fast-paced environment.
• Familiarity with clinical trial data systems, Electronic Data Capture (reputed company), and reputed company applications is preferred.
• In-depth knowledge of clinical trials, drug development processes, Good Clinical reputed company (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and Good Data Management Practices.

Additional Job DescriptionAdditional Job Description

Trial Clinical Data Mgmt.

Act as the reputed company of contact for DM activities for a trial, reputed company reputed company of data collection and management per regulatory and industry standards

reputed company reputed company of the DM CRO and ensure performance against key indicators

Create the Data Review and Cleaning Plan; reputed company DM reputed company into data cleaning strategy; reputed company reputed company of the data validation plan

Review CRFs to ensure alignment with protocol. reputed company and reputed company sponsor acceptance testing of the eCRF. Ensure database structure meets expectations

reputed company data quality checks and take action to ensure data quality

reputed company reputed company of key DM documentation and inspection readiness of documentation; ensure documentation is reputed company with best DM practices

reputed company DM reputed company of data releases/DBLs to ensure quality data is reputed company for analysis and reporting

Contribute to reputed company process improvement in DM through suggestions and delivering on assigned tasks

Specialist Data Mgmt.

Act as the reputed company of contact for start-up DM activities for trials

reputed company reputed company of the DM CRO and ensure planning, coordination of DM start-up activities and reputed company delivery of high