Associate Director, Clinical Data Management

Location
Working from home
Posted
Jul 03, 2021
Required Education
Bachelors Degree
Position Type
Full time
BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh, with small satellites in other parts of the country. 

To learn more, visit us at https://bridgebio.com

Who You Are:

The Associate Director, Clinical Data Management is responsible for leading internal and outsourced Clinical Data Management personnel and activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk‐Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness.

Other responsibilities include a contribution to the definition of defined company data standards and conventions. Functioning as an advisor for Clinical Data Management activities to all project teams as well as the staff under direct supervision. Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices. May contribute to department and other project budget planning.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all ML Bio policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.

Responsibilities:
  • Provides vendor oversight to ensure quality and timeliness of deliverables, compliant with the study requirements, SOPs and GCPs
  • Represents clinical data management or oversee vendor DM representation in meetings with relevant cross-functional teams, external vendors, and regulatory agencies
  • Directs DM activities (could be via a vendor) through program lifecycle including design and development of study database/EDC, user acceptance testing, query management, and database lock
  • Create or oversee vendor creation of thorough data quality checks and data review strategies to ensure the integrity of the clinical data
  • Oversees reconciliation between EDC and non-EDC data such as labs and, in collaboration with Pharmacovigilance, SAE reconciliation
  • Contributes to the development of outsourcing strategies and relationships with external partners or CROs
  • Budget assessment, training, and oversight for all DM services from study start-up through study close-out and final reporting
  • Responsible for managing and tracking work orders associated with clinical DM activities to ensure the operating costs for the DM department are within budget
  • Possesses excellent interpersonal communication skills (written and verbal)
  • Strong attention to detail
  • Previous CDSIC experience is desired
  • Proficient in the use of clinical data management systems (e.g. Oracle Clinical and/or Medidata Rave)


Education, Experience & Skills Requirements:
  • Bachelor’s Degree with significant relevant work experience in Clinical Research, Computer Science, Project Management, or related field
  • Experience within a clinical data leadership role in the pharmaceutical/device industry or CRO (preferably within a medium/large pharma or CRO)
  • Advanced knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.)
  • Excellent ability to work in a matrix environment and communicate effectively with different functional groups across the organization
  • Excellent ability to foster open communication and practice active listening to encourage a collaborative team environment
  • Demonstrates a solution-oriented approach to problem-solving and a “can do” attitude
  • Advanced knowledge of research and development, clinical trial execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting)
  • Advanced knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials


Who You Are:
  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to how we can improve our efforts
  • A culture inspired by our values: put patients first; think independently, be radically transparent; every minute counts, and let the science speak
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so


We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.