Senior Manager

4 weeks ago

Boston, United States Bicara Therapeutics Full time

POSITION SUMMARY

The Senior Manager of Clinical Data Management will execute data deliverables for all phases of clinical trials and programs as part of the clinical development group. This role will proactively participate within cross functional teams of internal clinical colleagues as well as external contract research organizations and other data vendors, driving end-to-end data quality and integrity from source through to submission.

The Sr. Manager of Clinical Data Management will also contribute to the development of departmental documents and procedures.

KEY RESPONSIBILITIES

• Functions 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.

• Assist in review of vendor proposals, budgets, scopes of work; Provides input to protocols, and other clinical study documents during development.

• Review and manage key documents such as data management plans, guidelines for CRF completion, data review, SAE reconciliation, Vendor Oversight, TMF plans, and data audits.

• Following CDISC conventions, oversee or perform eCRF design and annotation, database design specifications; Develop or oversee CRO generation of data edit check specifications (DVS); Participate in user acceptance testing (UAT) of the clinical database, including edit check testing.

• Create Bicara specifications for internal study team data review plan.

• Lead internal study team in data review; Perform data review for quality issues and general data trends; generate queries as necessary.

• Define/oversee data transfer specifications for external data sources (labs, ECGs, PK, eCOA) and transfer of data; reconcile or oversee CRO lab reconciliation with clinical database.

• Work with SAS and/or clinical systems programming to produce in-process data reports and data visualization tools to facilitate decision making on clinical trials (e.g., safety reviews). Provide input on standard tools and reports.

• Study DM liaison with cross-functional team members and external vendors to ensure completion of all timelines and study-related tasks; Ability to work independently as well as within a cross-functional team environment.

• May give Data Management presentations and/or training at investigator or other meetings.

• Participate in development and implementation of departmental initiatives. Reviews and provides input to improve data management SOPs and guidelines.

• Contribute to content development and/or testing of department standards.

REQUIREMENTS

• Strong understanding of end-to-end Clinical Data Management in a biotech or pharma environment

• Oncology and phase 2/3 experience preferred

• Sr. Manager level

• Experience working with DM vendors and CROs highly desirable

• Familiarity with Medidata RAVE and/or other clinical data management software preferred

• Experience executing UAT scripts for testing of electronic data capture systems including eCOA (Electronic Clinical outcome assessment) systems

• Knowledge of GCP and other regulations

• Must have excellent oral and written communication / presentation / negotiation skills

• Ability to manage multiple (changing) priorities under tight timelines

• Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner

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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