Clinical Trials Manager
Synta has an opening for a Clinical Trial Manager to support investigator sponsored studies.
- Manage Investigator sponsored trialss to ensure that studies are conducted efficiently, on time, within budget and in accordance with Synta SOPs and applicable regulatory requirements.
- Liaise with medical monitor/medical liaison and cross functional team members as necessary and in accordance with Synta SOPs to produce required study deliverables (e.g., clinical protocols, CRFs, informed consent templates, data management plans, safety plans, quality plans, monitoring plans, pharmacy manuals, clinical study reports etc.)
- Manage assigned clinical operations team members to ensure coordinated execution and quality of deliverables.
- Responsible for the identifying potential vendors, managing the “request for proposal” process, reviewing proposals and leading the vendor selection process.
- Manage the CROs and vendors for assigned trials to ensure execution and quality of the clinical trial and assigned deliverables. Responsible for managing all vendors to the signed contract and budget terms.
- Identifies issues and implements solutions to ensure the project remains on timeline. Informs management of significant issues in a timely way.
- Work with Program Management and Finance to reconcile monthly actual and forecast budgets.
- Chair cross functional study team meetings and maintain meeting minutes and action items for team.
- Ensure cross-functional issues are resolved swiftly and successfully.
- Additional responsibilities as assigned.
- Bachelor’s degree.
- Two to four years of experience as a Clinical Trial Manager.
- Excellent Project Management skills.
- Must be highly organized and have the ability to multitask.
- Excellent verbal and written communication skills.
- Proficient in Microsoft Office applications including word, excel, powerpoint, and outlook.
- Knowledge of GCP, ICH and applicable National and International regulatory guidelines.
- Ability to travel 10%.
- Oncology experience preferred.
- Investigator sponsored study experience