- Proactive management and oversight of CRO and other external provider partners (e.g. central laboratories, specialty laboratories, etc.) to ensure strong delivery of data-related services.
- Drive the risk-based quality management (RBQM) process for one or more clinical trials. Leading study risk assessments, defining risk mitigation measures, and monitoring effectiveness, to ensure high quality data and associated documentation.
- Data quality surveillance of CRF and external/non-CRF clinical trial data (e.g. Biosample Lab Data, Biomarker Data, Imaging) in collaboration with other Clinical Operations roles, Medical Monitors, Translational Medicine, Clinical Pharmacology, Biostatistics, and other internal and external stakeholders.
- Creating and/or contributing to study level documentation, e.g. study risk assessments, data management plans.
- Contribute to defining and maintaining CRF and/or external/non-CRF data standards, ensuring adherence across clinical studies.
- Overseeing or acting as intermediate between Data Management, Statistical Programming and external data provider regarding external data specifications, data, and technical issues.
- May provide specific subject matter expertise working across all clinical trials, e.g. medical coding, external data management, etc.
- Assisting and providing study level support to study teams and other team members as needed.
- Develops and maintains standard operating procedures, work instructions, and study-specific process documentation necessary to support effective data management while adhering to quality standards and industry regulations.
- Provides risk-based quality management upport and expert guidance to internal stakeholders including, but not limited to other Clinical Operations roles, Medical Monitors, Translational Medicine, Clinical Pharmacology, and Biostatistics.
- Ensures strong inspection readiness application for all clinical data and related documents.
- As needed, ensures quality and the timely delivery of patient sample information according to project needs.
- Bachelors degree or above in a biological science or health related field.
- Knowledge and experience working with industry standard coding dictionaries, e.g. MedDRA, WHODrug. Certified MedDRA Coder (CMC) examination completion is a plus.
- Knowledge of managing external data processes for data management. This includes creation of external data transfer specifications; leading study level UAT and QC of external data transfers; performing reconciliation data checks on external data.
- Minimum 8 years' experience in a pharmaceutical/biotech setting preferred.
- Experience in technologies such as Medidata modules (RAVE, Coder, RTSM, eCOA), Veeva eTMF, eClinical Solutions Elluminate, SAS LSAF.
- Advanced knowledge of GCP/ICH standards, GAMP 5.0, 21 CFR Part 11, CDISC requirements is a plus.
- Experience leading and/or contributing to protocol risk assessments, defining risk mitigation actions, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs), within RBQM tools or platforms to ensure proactive data quality management.
- Advanced leadership skills and ability to work within cross-functional teams.
- Excellent interpersonal, organizational, and multi-tasking skills.
- Travel domestic and international - up to 15%
- Hybrid position based in Waltham, MA
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Associate Director, Clinical Data Management - Waltham, United States - MURAL ONCOLOGY PLC
Description
Associate Director, Clinical Data ManagementThe Mural Oncology team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated and experienced data professional to join our team.
As part of the Clinical Operations organization, and within the Clinical Data Management team, the Associate Director, Clinical Data Management is a critical role to ensuring the highest quality clinical trial data is available to support company objectives and claims.
In this role, the primary focus will be on providing quality oversight and ensuring proactive collaboration with our CRO partners and other external vendor partners.
Similarly, it will be equally as important to cultivate strong working relationships with various internal stakeholders across different departments.Position Summary:
Responsible for the proactive management and timely delivery of high quality data for one or more clinical trials.
May be expected to specialize in key process areas working across the clinical trial portfolio, developing deep subject matter expertise in the Clinical Data Management team, advising and training other members of the team as needed.
Duties and Responsibilities:
Education/Skills and Experience Requirements:
Physical Demands and Work Environment:
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Mural Oncology is an E-Verify employer.
