Senior Manager, Clinical Data Management

2 days ago

Boston, United States Bicara Therapeutics Full time

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.


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 biotechnology company developing first-in-class biologics

engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com.


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.

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