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Associate Director / Director Clinical Data Management

Employer
Alkahest, Inc.
Location
San Carlos, California
Start date
Apr 12, 2021

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Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Alkahest is a clinical stage biopharmaceutical company targeting neurodegenerative and age-related diseases with transformative therapies derived from a deep understanding of the plasma proteome in aging and disease.

We are seeking an Associate Director/Director, Clinical Data Management to oversee all aspects of clinical data management. Responsibilities include leading data management activities during study planning, start-up, conduct, and reporting across all phases of clinical trials; selection and oversight of vendors/CROs for Data Management and statistical services; preparation of data reports and graphical representations as needed to support project needs; working collaboratively with the project team to ensure that data management services are delivered in a consistent, high-quality manner; and providing strategic direction to support the company’s overall Data Management needs as the company grows.

Responsibilities

  • Develop and manage timelines for key clinical data management deliverables. 
  • Coordinate the design, testing, and release of data capture systems based on protocol requirements.   
  • Direct the development, management, and execution of the study Data Management Plan (DMP) which includes the data collection strategy and User Acceptance Testing (UAT), Case Report Form (CRF) design, CRF completion guidelines, SAS annotated CRFs, data entry review guidelines, edit check specifications, data transfer specifications, data reconciliation plans, and database audit plans, as well as other aspects of data collection and management in the context of clinical development. 
  • Lead teams to review data quality reports. Generate, resolve, and track data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications. Identify and resolve data management issues, in coordination with other departments and contract data management groups, as appropriate.  Direct the interaction with contract data management groups to ensure that data management tasks remain on target according to project timelines and budget. 
  • Utilize appropriate software to coordinate the completion of various duties, including data transfers and quality reviews of the database, database lock and release, archival of data management documentation and files, and coordination of coding for the adverse event and medication dictionaries.
  • Work with Clinical, Biostatistics, Medical Writing, Regulatory and project teams to provide data reports and graphical representations as needed to support safety review, internal decision making, regulatory submissions, and publications. 
  • Participate in the development and review of study documents including Clinical Protocol, Statistical Analysis Plan (SAP), and Clinical Study Reports. 
  • Oversee CRO data management services and conduct/supervise inspections and audits, as appropriate.  
  • Ensure compliance of clinical data management processes with applicable regulations and guidelines.
  • Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives.

Qualifications 

  • Bachelor/Master’s degree or equivalent.
  • A minimum 7 years of pharmaceutical development experience with at least  5 years of progressive experience in clinical data management.
  • Advanced knowledge of Data Management processes and systems, including design and maintenance of Electronic Data Capture (EDC) systems.
  • Must have strong computer system skills with a proficiency in Microsoft applications (Word, Excel), programming languages/tools (e.g., SAS, Java, C++,  J-Review, SpotFire), and relational databases (SQL, PL/SQL, etc.)
  • Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements.
  • Strong problem-solving abilities and organizational skills. 
  • Able to work both independently and collaboratively on multi-disciplinary project teams, and develop productive relationships with external vendors.
  • Strong verbal and written communication skills as well as interpersonal skills.
  • Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities.

Company

At Alkahest, we strive to lead the way towards effective therapies for patients suffering from diseases associated with the detrimental processes of aging. We believe that as an industry, we simply haven’t done enough to help drive solutions for the most under-treated and devastating diseases affecting this growing demographic. We want to help.

Aging is the dominant risk factor in degenerative diseases. Many of the pressing age-related and neurodegenerative diseases have a profound impact on patients and their caregivers, yet have very limited treatment options. Alkahest has embarked upon a simple but elegant approach to treat disorders of aging by capitalizing on the body’s own natural regulatory and communication mechanisms, leveraging the plasma proteome. The promise of this science, and the potential to make a difference to patients around the world, was the founding principle of Alkahest.

For all of the great progress we have made so far, we credit our dedicated and impassioned team for driving our successes. Our culture is warm and supportive, genuine and ethical, rigorous and scientific, and collaborative yet entrepreneurial. Based in Silicon Valley, home to many leaders in the biotechnology industry, the heart of our culture is scientific innovation. We work hard, yet we have fun while we’re doing so. We are passionate about both our collegial atmosphere as well as working together on cutting-edge therapies that will change the lives of patients. We know we have a lot further to go, and we’re ready for the long haul.

Company info
Website
Phone
650-801-0474
Location
75 Shoreway Road, Suite D
San Carlos
California
94070
US

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