Project Manager

Comprehensive Clinical Development (CCD) formerly known as Comprehensive NeuroScience, Inc. (CNS) provides early phase pharmacology and specialty clinical trials. CCD plays a key role in advancing the development of innovative drugs and treatments for humans. With locations from coast to coast, CCD is a trusted provider to many of the world’s leading pharmaceutical companies, setting the highest standards in service, reliability and quality. Please visit our website at: www.comprehensivecd.com
 
Essential Functions

 

The Project Manager will be responsible for:

 

·         Identify the goals, objectives and requirements, and limitations of an assigned project.

·         Coordinate the different needs and expectations of the various projects stakeholders including team members, resource managers, senior management, customers, and sponsors.

·         Plan, execute, and control the tasks, phases, and deliverables of the project based on the identified project goals and objectives.

·         Close the project when completed and capture the knowledge accrued.

 

The project manager is charged to take a leadership role in the maintenance of Clinical Development standards and integrate good clinical practices and best organizational practices into the overall project development plan.

 

Specific Duties Include

 

·         Act as the primary contact for their respective areas (sponsor, clinical sites, consultants and medical writers) and liaison between client and the investigational study site personnel to ensure the safety of subjects, accuracy of data, and operational success of the study and project.

·         Develop and maintain site-specific study management and communication plans to increase the clinical site's level of operational success. Communicate effectively with clinical site study staff as necessary and document pertinent communication. Identify and resolve site and study related issues.

·         Track and monitor enrollment at the clinical sites. Provide strategic recommendations in the event enrollment is not meeting expectations.

·         Instruct investigator site staff in their responsibilities and ensure compliance with GCP and ICH guidelines. Ensure appropriate, timely training of all study site personnel.

·         Assist the investigational site in the management of timely query resolution.

·         Manage time effectively in order to fulfill requirements to meet all timelines, in both project work and submission of administrative documents.

·         Participate in project level budget planning, review and tracking of deliverables

·         Adhere to CNS SOPs and utilize approved forms

·         Timeline tracking and on-time completion of project milestones and internal development work

·         All other duties as assigned

 

Qualifications

 

Education

 

·         Minimum of Bachelors Degree in Related Field or R.N.

·         Combination of college education, training and experience that provides the knowledge, skills and abilities to perform the job in lieu of Bachelor’s degree in designated field of study may be considered with approval from CNS Senior Management.

·         ACRP CCRC or SOCRA CCRP certifications are requiered.

Minimum Work Experience

 

·         5 years in the CRO (Clinical Research Organization) or Pharmaceutical industry or Client Service based company

·         5 years in Project Management or Senior CRA / Lead CRA experience.

·        Generics highly desired.

** Please forward resumes in confidence to: zlall@cnsmail.com **