Manager, Clinical Operations at Nuvalent overseeing clinical trial planning, execution, and data collection according to regulatory guidelines. Responsible for various aspects of clinical study conduct and ensuring high - quality results.
About the role
- Clinical Project Manager managing Class II and Class III medical device clinical trials for Cochlear. Leading teams and ensuring compliance with regulatory standards in a hybrid work environment.
Responsibilities
- Lead a multi-disciplinary team in the conduct of a cost-effective, ethical and results focused, publishable study that supports the defined business objectives.
- Oversee Site Qualification, Site Initiation, Interim and Close-out Monitoring Visits to ensure Investigator Compliance.
- Liaise with Clinical Research Associate (CRA) to create and implement required study documentation and plans including the study protocol in line with local Institutional Review Board (IRB) or Ethics Committee (EC) requirements, local regulatory guidelines and SOPs to ensure that all studies are conducted in a compliant manner.
- Manage site and subject enrollment, receipt of clinical data and reporting of adverse events to established timelines.
- Act as primary contact between clinic trial sites and sponsor for all study specific needs including routine investigator updates.
- Create and distribute study related metrics to internal and external stakeholders including weekly and monthly updates within team, cross functional teams or senior management, and externally for clinical study sites.
- Anticipate potential obstacles to clinical study success, prepare and communicate contingency plans and implement process improvements.
Requirements
- Bachelor’s degree and 3 to 5 years of medical device or pharmaceutical clinical research experience or an advanced degree in hearing science, audiology or related field and 1 to 2 years of medical device or pharmaceutical clinical research experience.
- Clinical Research certifications from ACRP or SOCRA preferred.
- Intermediate knowledge of Good Clinical Practice (GCP), International Conference of Harmonisation (ICH), Code of Federal Regulations (CFR) and ISO14155 (CITI Certification preferred).
- Experience with electronic data capture (EDC) and electronic trial master file (eTMF) systems, project planning and managing budgets.
- Travel is required at 30%.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Life and disability insurance
- 401(K) matching with immediate vesting
- Paid Time Off
- Tuition reimbursement
- Maternity and paternity leave
- Employee Stock Purchase Plan
- Pet insurance
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