Fusion Pharmaceuticals | Data Manager/Sr. Data Manager | boston, ma

1 week ago

boston, United States Fusion Pharmaceuticals Full time

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes, but is not limited to: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. Fusion has multiple other pipeline programs that will soon be entering into early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet supply demand for our growing pipeline of RCs.


The Data Manager/Senior Data Manager will be accountable for global delivery, integrity, and quality of Fusion’s clinical data for one or more programs. This individual will serve as an in-house data management expert for one or more assigned programs. The Data Manager, Data Management is responsible for preserving data integrity and adhering to deadlines to achieve accurate and timely regulatory submissions and publications for all assigned projects. This employee will report to the Sr./Director, Data Management.


Key Responsibilities


• Lead Data Management activities to support ongoing clinical programs. If Data Management activities for a study are performed by a vendor, oversight of activities such as eCRF development, database set-up activities, data validation process, medical coding, SAE reconciliation, training of study site personnel in CRF completion, lab data transfer specifications, and data clarification processes.

• Support data review activities (cleaning activities, including internal cross functional listing review, external data reconciliation and data review). Support all activities leading to the study database lock.

• Ensure Data Management activities are conducted according to applicable regulations and per the protocol.

• Support Data Management lead on one or more clinical programs and actively participate in clinical trial study team meetings (CSTs).

• Support development of the Data Management Plan (DMP) for assigned programs and maintain throughout lifecycle of study project to ensure DMP is followed according to study design and requirements Prepare the Data Transfer Agreements (DTA) or oversee the development of DTAs between the Data Management CRO and the External data vendors.

• Participate in departmental developmental initiatives (e.g. training, SOP development, etc.)

• Responsible for archiving data and study specific data management documentation.



Qualifications


• Requires a bachelor’s degree in a scientific discipline or equivalent.

• At least 2 years as a Data Manager in a Pharmaceutical/Biotechnology company, or CRO.

• Proficient in Electronic Data Capture (EDC) systems such as Medidata Rave, InForm.

• Understanding of CDASH, SDTM, and medical coding dictionaries MedDRA, WHO Drug.

• Good understanding of ICH, GCP and other applicable regulatory guidelines.

• Effective verbal and written communication skills. Capable of working on multiple projects simultaneously.

• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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