Associate Director/Director, Clinical Data Management
Apply NowCompany: Harbinger Health
Location: Cambridge, MA 02139
Description:
Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis, and management. Incubated within Flagship Pioneering for three years before launching in 2021, Harbinger combines advances in artificial intelligence with proprietary insights into the biology of early cancer cell formation to identify cancer before it is visible or symptomatic with the aim of developing low-cost, multi-cancer blood tests.
At Harbinger, we intend to lead in shaping this future - creating a proactive paradigm so that people can live cancer-free for longer, adding years to life and life to years. We envision a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies.
Our answer starts with proprietary solutions we are developing with our platform technology. By making cancer screening accessible on a global scale, Harbinger Health has the potential to fundamentally change cancer care, for everyone.
Our lifesaving work is grounded by our principles of rigor and transparency, constructive engagement, inclusiveness, accountability and quality, and a strong commitment to our customers, patients, and each other. These values drive our decisions and actions. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.
Job Description - Associate Director/Director, Clinical Data Management
Position Summary
As Associate Director/Director, Clinical Data Management at Harbinger Health, you will oversee the clinical data management processes across our portfolio, ensuring seamless data flow from clinical trial planning through to data generation and database lock. Reporting to the SVP of Clinical Operations, you will initiate best practices, manage clinical data management vendors, and work closely with CROs to ensure the integrity of data management processes. This role demands a proactive approach to cross-functional collaboration, a deep understanding of clinical trial data standards, and expertise in vendor oversight, making you a key player in advancing our clinical data capabilities.
Responsibilities:
Qualifications:
Preferred Qualifications
Harbinger Health is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Harbinger Health does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Harbinger Health or its employees is strictly prohibited unless contacted directly by Harbinger Health's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Harbinger Health, and Harbinger Health will not owe any referral or other fees with respect thereto.
At Harbinger, we intend to lead in shaping this future - creating a proactive paradigm so that people can live cancer-free for longer, adding years to life and life to years. We envision a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies.
Our answer starts with proprietary solutions we are developing with our platform technology. By making cancer screening accessible on a global scale, Harbinger Health has the potential to fundamentally change cancer care, for everyone.
Our lifesaving work is grounded by our principles of rigor and transparency, constructive engagement, inclusiveness, accountability and quality, and a strong commitment to our customers, patients, and each other. These values drive our decisions and actions. We are a highly dynamic, entrepreneurial, and innovation-driven organization seeking collaborative, passionate, and dedicated people to join our team.
Job Description - Associate Director/Director, Clinical Data Management
Position Summary
As Associate Director/Director, Clinical Data Management at Harbinger Health, you will oversee the clinical data management processes across our portfolio, ensuring seamless data flow from clinical trial planning through to data generation and database lock. Reporting to the SVP of Clinical Operations, you will initiate best practices, manage clinical data management vendors, and work closely with CROs to ensure the integrity of data management processes. This role demands a proactive approach to cross-functional collaboration, a deep understanding of clinical trial data standards, and expertise in vendor oversight, making you a key player in advancing our clinical data capabilities.
Responsibilities:
- Lead and manage clinical data management processes across all trials within Harbinger Health's portfolio.
- Oversee clinical trial planning and data management from trial initiation through database lock.
- Implement best practices for clinical data management workflows and ensure vendor oversight for data transfers and handling.
- Manage partnerships with clinical CROs and provide oversight for outsourced clinical data management activities from RFP to database lock.
- Collaborate with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools.
- Design and/or develop database structures, edit checks, CRF completion guidelines, and Data Management Plans in accordance with CDASH and SDTM standards.
- Work collaboratively with cross-functional teams including Biostatistics, Statistical Programming, Clinical Operations, Translational Science, Medical, Data Science, Digital, and Lab Personnel to ensure standardized data collection and reporting.
- Collaborate with internal and external stakeholders, including software vendors and clinical development partners, to meet project timelines and budgets.
- Attend study team meetings, providing updates on data collection and resolving data-related issues to ensure the trial data is ready for early-phase deliverables.
- Additional duties and responsibilities as required.
Qualifications:
- B.S./M.S. and a minimum of 8 years of clinical data management experience in industry and familiarity with EDC platforms.
- At least 3 years of management experience in a clinical research environment, preferably in oncology.
- Strong vendor management and oversight experience.
- Expertise in designing clinical trials utilizing CDASH and SDTM standards.
- Experienced in cross-functional collaboration with Biostatistics, Clinical Operations, Translational Science, Medical, Data Science, Digital, and Lab Personnel.
- Deep understanding of FDA and ICH GCP guidelines to ensure accurate reporting of clinical trial data.
- Experience with data visualization software.
- Proven ability to manage multiple projects in a fast-paced environment.
Preferred Qualifications
- Experience in oncology and/or diagnostics.
- Familiar with genomic assays.
Harbinger Health is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Recruitment & Staffing Agencies: Harbinger Health does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Harbinger Health or its employees is strictly prohibited unless contacted directly by Harbinger Health's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Harbinger Health, and Harbinger Health will not owe any referral or other fees with respect thereto.