Oncology Clinical Project ManagerApply Now

Category: Clinical Project Management
Location: Home Based
Salary: TBD

Job Description:

Job Summary:

The Project Manager offers an additional development path for clinical research professionals. Responsibilities are dependent upon the type and timing of the program to which the Project Manager is assigned.

This position requires the ability to independently manage an appropriately sized clinical program in accordance with the study budget and scope of work. The Project Manager is a leadership position that requires supervisory experience. Candidates for this position are expected to have strong interpersonal and organizational skills, allowing them to set and achieve objectives in the execution of the programs to which they have been assigned. Project Managers are also expected to support the Project Directors and Director of Clinical Operations in the training and mentoring of junior staff

Description:

 Serves as primary point-of-contact liaison with client to provide outstanding customer service, including participation in proposal activities and client presentations.
 Oversees and manages all aspects of a clinical research trial
 Manages the clinical study budget, ensuring project remains within
 Establishes tracking metrics to monitor trial and team progress towards project goals
 Prepare project status updates for clients and Sr. Management
 Serves as a member of the Project Team with the goal to contribute towards efficient management of trials.
 Prepares and reviews of protocols and other study documentation.
 Designs and develops CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.
 Oversees all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
 Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
 Establishes tracking metrics to monitor trial and team progress towards project goals
 Prepare project status updates for clients and Sr. Management
 Serves as a member of the Project Team with the goal to contribute towards efficient management of trials.
 Prepares and reviews of protocols and other study documentation.
 Designs and develops CRF and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc
 Oversees all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports.
 Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
 Manages site start up procedures including the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by the project manager.
 Negotiates study budgets and assists with the execution of investigator contracts with support from the legal department.
 Conducts all forms of monitoring visits, including pre-study, initiation, routine, and final monitoring visits, in accordance with the protocol, local laws, ICH- GCP and Advanced Clinical Trial Solutions’ SOPs.
 Prepares accurate and timely visit reports from all monitoring visits.
 Communicates effectively with both site personnel and company management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
 Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote company high quality and ethical image.
 Maintains study tracking, in accordance with the demands of the study.
 Performs data management activities, including in-house CRF review, query resolution, and assists data management personnel resolve data discrepancies


Job Requirements:

Requirements:

 Graduate, postgraduate, 4-year college degree, in a scientific or healthcare discipline.
 5 years or more in Clinical Project management with a CRO company. Direct supervisory or experience managing people is expected in candidates for this position.

Apply Now

SEARCH JOBS...

NEWEST JOB LISTINGS...

View JobR&D QA Auditor Specialist
RTP, NC

View JobSenior Director, Product Quality/Occupational Toxicologist
Sf Bay Area - Philadelphia, PA

View JobAssociate Director, Clinical Operations
Princeton, NJ