Principal Data Manager, Alira Health
Patient-centric advisory firm
Job no longer available
Patient-centric advisory firm
501-1000 employees
Job no longer available
501-1000 employees
Company mission
To humanize healthcare and life sciences in partnership with patients.
Role
Who you are
- Extensive data management processes knowledge
- Proven ability in leading data management activities for client, including complex projects
- Ensure DM tasks for the assigned studies are performed on time and within budget
- Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacology
What the job involves
- In the role of FSP Principal Data Manager you will perform CRO oversight on the assigned projects, ensuring CRO is delivering on time, at the expected quality and within budget
- Act as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective
- Review and monitor Data Management timelines for assigned projects and ensures that all the team members are aware and on target for deliverables
- Review and approve all data management deliverables (e.g. CRF specifications, Data Management Plan, Data Validation Plan, External data stream Data Transfer Specification, Reconciliation plan etc)
- Contribute to, review and approve Randomization, Drug Supply, ePRO/eCOA specifications
- Perform User Acceptance Testing to ensure the eCRF and annexes (i.e. Randomization, Drug Supply, ePRO/eCOA) are ‘Fit For Purpose’
- Bridge scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets
- Proven ability to analyze data capture problems/opportunities and a track record of developing and delivering high quality solutions
- Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM
- Effective relationship management with vendors in order to meet expectations and achieve results
Our take
The healthcare industry has been rapidly digitizing in recent years, and Alira Health is at the forefront of this transformation. The company works closely with healthcare and life sciences organizations, providing support across the entire solutions lifecycles. From market research to end-to-end product development, Alira Health enhances clients' expertise with a broad range of services and technology-driven consulting.
In early 2021, Alira Health strengthened its offering by acquiring Chamow and Associates, a leading biopharmaceutical consultancy. This acquisition expanded ALira's capabilities in regulatory affairs and product development, allowing the company to offer even more comprehensive support to pharmaceutical companies navigating complex processes.
With renewed funding and the 2022 renewal of the 21st Century Cures Act, Alira Health is well-positioned for further growth. The legislation, which empowers patients with greater control over their data and streamlines the process for drug and medical device developers, opens new doors for innovation. Allowing Alira to explore fresh opportunities to engage patients, healthcare providers, payers, and suppliers in more meaningful ways.
Freddie
Company Specialist at Welcome to the Jungle
Insights
6% employee growth in 12 months
Company
Company HQ
Framingham, MA
Leadership
Gabriele Brambilla
(CEO)Joined Alira Health in 2014 as CEO. Alongside this, they serve on the Board of Directors for EnlightenVue, WWoundForce, Firefly, and Computational Life. In 2018, they co-founded the MetroWest Life Sciences Network to develop collaboration, innovation and entrepreneurship in Boston's MetroWest life sciences ecosystem.
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