Position Overview:

The Sr. Manager, Clinical Data Management will be responsible for performing activities that help to ensure compliance with data quality and documentation standards. This role will perform process and data audits and will trend outcomes to identify quality or training gaps. This role will engage with Data Management vendor staff to provide feedback as necessary. He/She will work closely with Clinical Data Management to support the development and QC of UAT scripts for EDC and eCOA systems and will be the main resource that will execute the study level UAT for these systems. The Manager, Clinical Data Management will also be responsible for the Internal Data Review process at Bicara. He/She may also function as a Study Data Manger as required. We are ideally seeking Massachusetts-based candidates who are able to work a hybrid schedule that includes 3 days per week in our Boston office.

Responsibilities:

• Creates Bicara specifications for internal study team data review plans
• Leads or helps to facilitate internal study team in data review;
• Performs audits to ensure that the internal and DM Vendor staff complete activities according to defined processes and specified quality standards
• Performs data and query audits to ensure internal and DM Vendor staff are cleaning data according to specified quality standards
• Reviews and/or creates user acceptance test (UAT) plan/ scripts for quality and completeness of electronic data capture (EDC) systems including Electronic Clinical outcome assessment (eCOA) systems
• Perform UAT (Screen setup testing and Edit checks testing) to ensure high quality EDC / eCOA system setup, compliance with industry and Bicara’s best practices
• Schedules and leads meetings to provide feedback on the UAT issues to the project team (internal/vendor)
• Reviews study documentation and plans ensuring data quality is consistent with DM best practices, standards and procedures
• May write, update, and manage departmental SOPs and SOP review cycles
• Assesses trends in data and process audits and communicates lessons learned and recommends process improvements
• Develops and manages KPIs for data quality, process adherence, and productivity
• Ensure development of CRFs and edit checks in alignment with specifications
• Perform data cleaning and validation processes, including discrepancy management and data reconciliation.
• Ensure accurate and timely data entry, validation, and query resolution.
• Defines/oversees data transfer specifications for external data sources (labs, ECGs, PK) and transfer of data; reconcile or oversee CRO lab and/or scan data reconciliation with clinical database
• May function as internal Study Data Manager, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports; ensuring major DM deliverables and milestones are met

Qualifications:

• Bachelor’s degree in Life Sciences, Health Informatics, or a related field.
• Minimum of 5 years of experience in clinical data management, preferably within the pharmaceutical or biotechnology industry.
• Oncology experience required
• Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical, etc.) and clinical data management tools.
• Strong knowledge of ICH-GCP guidelines, and regulatory requirements.
• Excellent organizational, analytical, and problem-solving skills.
• Ability to work independently and as part of a team in a dynamic, fast-paced environment.
• Strong communication skills, both written and verbal.
• Attention to detail and a commitment to producing high-quality work.

Company Overview

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.