- 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.
- Responsible for the secure exchange of clinical trial data between Mural Oncology and external provider partners support one or more trials.
- Defining and delivering reporting content for use in managing clinical trial conduct in collaboration with other Clinical Operations and Clinical Data Management roles, Medical Monitors, Translational Medicine, Clinical Pharmacology, Biostatistics, and other internal and external stakeholders. Reporting content could include CRF and external/non-CRF clinical trial data (e.g. Biosample Lab Data, Biomarker Data, Imaging), as well operational data.
- Collaborating with Statistical Programming and other internal/external stakeholders to align on SDTM reporting requirements, establish quality programming standards, and delivering SDTM datasets for various statistical analysis purposes.
- Creating and/or contributing to study level documentation, e.g. data management plans, data transfer specifications, SDTM specifications, report development requirements.
- May process external lab test transfers and work with external data providers to reconcile issues, if any.
- Contribute to defining and maintaining CRF and/or external/non-CRF data standards.
- May oversee or act 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. enterprise systems validation, vendor qualification, etc.
- Assisting and providing study level support to study teams and other team members as needed.
- May develop and maintain 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 technical support 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 computer science or health related field.
- Extensive experience in data visualization tools such as Tableau, Spotfire, Power BI.
- Advanced experience in programming tools such as SAS, Python, R, SQL.
- Experience with databases such as Oracle/Snowflake/SQL Server.
- Knowledge and experience working with industry standard coding dictionaries, e.g. MedDRA, WHODrug.
- Minimum 6 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.
- 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
Senior Manager, Clinical Programming - Waltham, United States - MURAL ONCOLOGY PLC
Description
The 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 Senior Manager, Clinical Programming is a critical role to ensuring secure exchange of clinical and operational data with external partner providers and delivery of reporting content and clinical trial data to internal and external stakeholders as needed.
In this role, the primary focus will be on proactively establishing stakeholders needs for access to data and ensuring proactive collaboration with our CRO partners and other external vendor partners to make this data available as needed.
Position Summary:
Responsible for the proactive delivery of clinical trial data for one or more clinical trials in various formats including, but not limited to, reports, visualizations, and SDTM datasets.
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.#J-18808-Ljbffr