Open Position
Title: Clinical Trial Manager
Location: Raleigh, NC Preferred (Hybrid Position)
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully-integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in New York City, New Jersey, and Raleigh, NC. For more information, visit www.tgtherapeutics.com.
Role
Clinical Trial Manager reports to the VP, Clinical Operations. He/she responsible for the successful planning, implementation and execution of clinical monitoring activities for assigned studies. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial. Assures clear vendor and internal team communication, process documentation, and compliance with Good Clinical Practices and procedures set forth by TG Therapeutics
Key Responsibilities
Responsible for all activities related to implementation and execution of clinical studies that include:
Coordinate site management activities:
——–– Work with Study Lead (SL) to define program targets for clinical monitoring staff
——–– Develop and implement Clinical Monitoring Plan.
——–– Overall scheduling and management of all site visits.
——–– Develop site/monitoring tools and training materials.
——–– Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.
Coordinate and oversee daily operations of clinical monitoring team:
——–– Set and enforce project timelines with the assigned study team.
——–– Coordinate remote review of clinical data within EDC system.
——–– Oversee monitoring visit schedule to ensure compliance with frequency set forth in Clinical Monitoring Plan.
——–– Review and approve trip reports and follow-up letters within required timeframe.
——–– Schedule and manage weekly CRA project team meetings.
——–– Ensure CRAs assigned to team receive therapeutic and project-specific training.
——–– Manage quality and regulatory compliance among clinical monitoring team and investigational sites.
Manage CRA performance:
——–– Define and implement functional standards, goals, and expectations with clinical monitoring team.
——–– Serve as CRA mentor and perform accompanied field assessment visits as required.
——–– Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of each respective CRA.
Documentation Duties/Responsibilities:
——–– Assure that the appropriate TG Therapeutics are followed.
——–– Ensure all project documentation is appropriately filed per TG Therapeutics SOPs.
——–– Assist PM in preparation of audit responses, as appropriate.
——–– Assist PM with preparation of information for inclusion in monthly report to client.
Professional Experience/Qualifications
––Minimum of 2 -3 years as a successful Clinical Trial Manager.
––Thorough knowledge of clinical research process.
––Prior experience as a Clinical Research Associate.
––Strong communication skills (verbal and written) to express complex ideas.
––Excellent organizational and interpersonal skills.
––Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
––Ability to manage multiple priorities within various clinical trials.
––Ability to reason independently and recommend specific solutions in clinical settings.
––Understanding of basic data processing functions, including electronic data capture.
––Working knowledge of current ICH GCP guidelines and applicable regulations.
––Able to mentor CRAs
––Willingness and ability to travel domestically and internationally, as required.
Education
––BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years direct experience in clinical studies or equivalent level of education and experience.
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.