Position Summary:
Biomea Fusion is hiring a Sr. TMF Specialist, who will be responsible for maintaining the operational aspects of the TMF system and supporting TMF-related activities. This is a contract position for approximately 6 months.
Essential Responsibilities:
- Uploading documents into the TMF
- Performing QC of the documents in the TMF
- Granting/Revoking User Access
- Sending out weekly reports to ensure timely resolution of any outstanding Quality Issues
- Owning Periodic TMF Functional QC Review cycles
- Leading Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs)
- Participating in Oversight Reviews of CRO-owned TMFs
- Assisting in TMF Reconciliations as needed
- Management of TMF activities as needed
- Overseeing the transfer of TMFs as needed
- Supporting the archival of TMFs as needed
- Working directly with functional area content owners as needed
- Participating in audits and assisting with inspection readiness activities as needed
- Partnering with CROs, vendors, and cross-functional groups to ensure adherence to TMF expectations
Education Requirement:
- Bachelor’s degree from an accredited institution or equivalent practical experience.
- At least 5 years of relevant TMF experience.
Preferred Skills:
- Fundamental understanding of filing systems and organization tools
- Knowledge and understanding of GCP/ICH and CFR Regulations
- Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint
- Familiarity with the CDISC Trial Master File Reference Model structure
- Experience with Veeva Vault Clinical (eTMF)
- Ability to work independently and prioritize tasks
Compensation:
The expected compensation rate is $40 to $50 per hour, dependent on experience and location.
Skills Required
- Bachelor's degree from an accredited institution or equivalent practical experience
- At least 5 years of relevant Trial Master File experience
- Fundamental understanding of filing systems and organization tools
- Knowledge and understanding of GCP, ICH, and CFR regulations
- Proficiency with Microsoft Word, Excel, PowerPoint, and SharePoint
- Familiarity with the CDISC Trial Master File Reference Model structure
- Experience with Veeva Vault Clinical eTMF
- Ability to work independently and prioritize tasks
What We Do
We are a biopharmaceutical company focused on the discovery and development of oral covalent small molecules to treat patients with metabolic diseases and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure and the ability to drive a deeper, more durable response. We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients. Our lead product candidate, BMF-219, is an orally bioavailable, potent and selective covalent inhibitor of menin, an important transcriptional regulator known to play a direct role in in regulating the growth of beta cells in the pancreas as well as oncogenic signaling in multiple cancers. Beyond BMF-219, we are utilizing our novel platform to develop treatments against other high-value metabolic diseases and oncogenic drivers of cancer. We entered the clinic with our second development candidate, BMF-500, a covalent inhibitor of FLT3 and are studying BMF-500 in acute leukemia patients. We also announced our third development candidate, an oral, small molecule GLP-1 receptor agonist in obesity. All our molecules, BMF-219, BMF-500, and our GLP-1 receptor agonist were developed in-house by the Biomea team. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure. The name biomea derives from the Greek word bios, meaning “life,” and the Latin word mea, meaning “my.” At Biomea Fusion, we develop medicines to improve the life of the individual. Visit us at biomeafusion.com
