CMK Select is seeking to hire a Clinical Trial Lead to oversee the operational execution of US Phase IV clinical studies, Investigator Initiated Trials (IITs), and compassionate use programs in support of our Pharma client. The Clinical Trial Lead will provide Phase IV clinical support including protocol development, review/reporting quality trial data, and study reporting/publishing. IIT program support responsibility will include the review and approval of strategically aligned studies, and management of budget.
The individual in this role will have accountability for the following key areas:
- Managing IITs, Phase IV trials, and compassionate use programs;
- Providing input to protocol design and operational aspects of trials;
- Writing protocol and informed consent study documents and study tools;
- Developing strategic trial execution plan (contingency plans) and timeline commitments for the US;
- Overseeing local vendor selection and performance;
- Leading and chairing Clinical Trial Team Meetings (CTT), and contributing to operations meetings;
- Managing initial and subsequent drug supply in collaboration with the Local Drug Supply Manager;
- Coordinating and managing the site selection process in collaboration with the CRO;
- Preparing clinical trialbudgets and forecasts and managing the IIT study program budgets;
- Driving the conduct of the trial, tracking and overseeing progress and status;
- Maintaining trialmaster file and ensuring collection of all documents, storage and scanning into archive database;
- Providing ongoing review of clinical trial data, coordinating data management activities through the CRO, driving database lock activities, and ensuring data complete activities;
- Providing input, and preparing clinical study report and appendices?
- Ensuring trial close-out activities arc performed, in close cooperation with field monitors and clinical trial head;
- Facilitating internal audits and HA inspections as required and assisting in audit response and implementation of corrective actions. following audits and inspections in relationship with Quality Assurance.
To excel in this role, a candidate should possess the following background and experience:
- Track record of successful execution of complex projects involving multiple stakeholders;
- Ability to influence effectively in a highly matrixed environment;
- 5+ years of experience in clinical research management;
- Experience in a monitor role or a role overseeing clinical trials;
- Experience in managing a project budget;
- Bachelors Degreerequired; Scientific or Healthcare discipline preferred.
CMK Select offers Medical/Dental/Vision Benefits Coverage, Paid Holidays, Paid Time Off, 401k and Generous Salaries, in addition to a Dynamic, Collaborative and Engaging Client Experience.