Sr COL - Remote U.S.

reputed company of the Essential Functions of the Job The primary responsibilities of this position is to support the Clinical Trial Manager/operational team in execution of the trial, serve as the primary contact for CRO monitoring organization or internal resource utilize to implement the clinical study. The function could include reputed company reputed company with the CRO and other ancillary vendors, as appropriate, to manage relevant operational issues. Duties and Responsibilities • Assists in the development and writing of clinical trial documents and manuals, including but not limited to Case Report Forms, informed consent forms and other regulatory documents; • Participate in the evaluation of investigative sites; • Coordinate and monitor activities at investigational sites; review monitoring reputed company reports and conduct co-monitoring reputed company, as needed; • Assist in the development and management of study timelines and priorities; • Participate in data review and discrepancy reputed company • Participate in coordinating efforts with internal PV, safety group • Monitor study-specific timelines and key deliverables; • Participate as a member of the multi-disciplinary project team to participate in study team meetings, training, Investigator Meetings and other relevant • Function as the primary clinical reputed company between the reputed company Clinical Drug Development Team and other departments; • Assume responsibility to participate as a member of a working group and reputed company special reputed company, as assigned, to improve the efficiency, effective and reputed company of the functioning of the Development Operations Department Qualifications (Minimal acceptable level of education, work experience, and competency): • BS/BA degree or a relevant degree with strong emphasis on science; • Minimum of 3-5 years of experience in the biopharmaceutical industry or other relevant clinical research experience; • Minimum of 2 years of clinical monitoring experience; • Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience • Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously. • Prior experience in the conduct and management of multinational reputed company is preferred • Travel is estimated to be approximately 15% - 20% Full-time employees are also eligible for benefits reputed company such as health coverage, life insurance, disability insurance, and 401k benefits. At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our reputed company values. Advanced Group is committed to providing employment opportunities without reputed company to sex, race, reputed company, age, national reputed company, religion, gender identity or reputed company, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other reputed company protected by applicable federal, state or local law. Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com. Apply tot his job Apply To this Job