Clinical Trial Manager

CenExel•Marlton, NJ

11d•$97,000 - $115,000•Onsite

About The Position

About Us: CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for the management of clinical research studies and the personnel assigned to those studies, under the direction of the Clinical Director. Compensation : $97,000-$115,000 depending on education, experience, and skillset.

Requirements

Bachelor's degree in related field or equivalent experience is preferred.
Minimum of three years of Clinical Research Coordinator or equivalent experience.
Ability to independently coordinate and manage complex protocols and to lead, motivate and train a clinical research team.
Experience managing and leading staff and implementing personnel procedures.
Professional image, upholding the company vision in actions, demeanor, and appearance.
Must be able to effectively communicate verbally and in writing.

Responsibilities

Manages all assigned clinical staff.
Reads and understands assigned protocols and leads and interfaces on such protocols with the study staff to achieve successful execution within appropriate timeframes.
Conducts Site Qualification Visits, as assigned.
Schedules and oversees Investigator Meeting arrangements, conducts initiation, study start-up, and team meetings.
Oversees scheduling and conduct of monitor visits.
Represents the clinical team during site visits.
Oversees preparation of, or personally prepares study-specific source documents for new protocols.
Reviews and modifies sponsor-provided source documents, when necessary.
Assists Study Coordinators in duties, as necessary.
On assigned protocols, assists to oversee delivery, shipment, inventory, storage, calibration and accountability of investigational products, supplies and equipment required to conduct clinical investigations.
Ensures optimum team function by assisting Clinical Research Coordinators with site start up, enrollment and study execution.
Is present for first patient randomized on each study.
Fields protocol questions from Clinical Research Coordinators.
Acts as the project lead, liaising between sites, investigators, monitors, clinical research coordinators, physicians, laboratory, pharmacy staff, and other study team members.
Assists with study in-services and other training needs as needed.
Oversees the following aspect of trials but is not limited to: Vendors, Client Satisfaction, Recruitment, Quality, Study Start-up and Trial Outcomes.
Monitoring the progress and completion of routine action items and ensuring timely follow-up.
Ensuring proper internal procedures are followed and documentation is obtained from coordinators for approval of retest, unscheduled visits, admits, AE treatments, etc.
Hires, trains, supervises, and evaluates personnel.
Champions and enforces the strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site Working Practices, protocol, and company guidelines and policies.
Retrains and implements corrective and preventative actions, as needed.
Assumes other duties and responsibilities as assigned.
The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.