Associate Director, Clinical Data Management

Position Overview

The Associate Director of Clinical Data Management is accountable for data management activities for all phases of clinical trials and programs as part of the clinical operation 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, serving as the internal expert in all areas of CDM processes and technology.

The AD of Clinical Data Management will also lead or contribute to the development of departmental documents and procedures and will oversee and/or mentor other data management personnel.

This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

* Review/Management of DM activities in vendor proposals, budgets, scopes of work

* Review and provide input to protocols, SAP, IB, CSR and other clinical study documents during development

* May be responsible for DM vendor oversight at program level. Function as internal DM Study lead, overseeing all data management activities performed by CROs including generation and review of metric status and patient tracking reports;
Work to ensure on-time achievement of major data management deliverables and milestones in coordination with other functions

* Review and manage key documents such as data management plan, CRF completion guideline, data review, SAE reconciliation, and data audits. Provide DM level review and input on all study medical coding

* 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 and guidelines (IDRP) with input from study team

* Lead internal study team in data review;
Perform data review for quality issues and general data trends; generate queries as necessary. Provide guidance to others on program-level internal data review standards.

* Define/oversee data transfer specifications for external data sources (labs, ECGs, PK) 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.

* Give Data Management presentations and/or training at investigator or other meetings

* Lead and/or participate in development and implementation of departmental initiatives. Develop or improve data management SOPs and guidelines

* May have direct reports; serve routinely as resource or mentor for other DM personnel. Partner with appropriate stakeholders for issue resolution

* Attention to detail and commitment to producing high-quality work.

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.

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…