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Bicara Therapeutics · 1 day ago

Associate Director, Clinical Data Mangement

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$190K/yr - $220K/yr

5+ years exp

Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing transformative therapies for patients with solid tumors. The Associate Director of Clinical Data Management will oversee data management activities for clinical trials, collaborate with cross-functional teams, and mentor other data management personnel.

BiopharmaBiotechnologyLife ScienceOncologyTherapeutics

Hiring Manager

Maggie Stokinger

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

Qualification

Clinical Data ManagementEDC Systems ProficiencyOncology ExperienceICH-GCP Guidelines KnowledgeRegulatory Requirements KnowledgeAnalytical SkillsOrganizational SkillsProblem-Solving SkillsCommunication Skills

Required

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

Bicara Therapeutics

Bicara Therapeutics develops dual-action cancer therapies, combining targeted treatments with tumor modulators for enhanced impact. It is a sub-organization of Biocon.

Founded in 2020

Cambridge, Massachusetts, USA

51-200 employees