Clinical Trial Manager III

Delta, a leader in the clinical research staffing and functional arenas.

 

Clinical Trial Manager III

 Summary of Position:

The Clinical Trial Manager III is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities.

Job Duties/Responsibilities:

? Performs job duties independently with minimal guidance from the Clinical Program Manager.

? Leads the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met

? Serves as primary contact for functional area representatives in managing protocol execution

? Ensures accuracy and timeliness of vendor and site payments

? Oversees forecasting of clinical/non-clinical supplies

? Establishes study milestones and ensures accurate tracking and reporting of study metrics

? Manages trial-specific collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials)

? Performs ongoing vendor management (e.g., CROs, IVRS, Reading Centers), including independent negotiation of vendors scope of works and budgets, performance management, and issue resolution

? Creates and manages clinical trial budgets and staffing/resourcing plans

? Provides study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate

? Provides support and mentoring to other Clinical Trial Managers

? Ensures trial adherence to ICH/GCP/local regulations

? Participates in clinical operations initiatives and programs as assigned

Competencies Identified for Success:

? Highly developed leadership skills to build and directs the Protocol Execution Team to ensure that timeline, cost and quality metrics are met

? Effective written and verbal communication skills

? Extensive experience developing trial plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management

? Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology

? Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners

Education, Experience, and Other Requirements:

? Bachelor?s Degree with a minimum of eight years of clinical research experience

? Therapeutic knowledge preferred

? Knowledge of GCP and ICH

? Proficient computer skills

? Travel may be required

These positions are basically what we worked on last year under the title, "Sr. Clinical Trials Manager" except these people will not be managing large groups of people any more.  They will be mentoring a few people but all true management of the people with be taken care of by the Functional Manager so the CTM III can devote all of their energy to managing the trial.

Full relocation packages including monetary awards for housing and sign on bonuses.

 

Location:  South San Francisco

Permanent Job

Contact Jay VanHousen/847-317-9544, ext. 245

jvanhousen@deltasi.com