Mgr Clin Review

The objective of a Clinical Review Manager, Clinical Data Management (CDM) is to manager the day-to-day clinical listings review activities, ensuring quality and timely review is performed consistent with requirements defined by procedure and project Data Validation Manuals.The Clinical Review Manager, CDM will provide supervisory functions for individual contributing staff with the CDM department, including developing and mentoring staff.The objective of a Clinical Review Manager, Clinical Data Management (CDM) is to manager the day-to-day clinical listings review activities, ensuring quality and timely review is performed consistent with requirements defined by procedure and project Data Validation Manuals.The Clinical Review Manager, CDM will provide supervisory functions for individual contributing staff with the CDM department, including developing and mentoring staff.Education and Experience:Bachelor's degree or certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)Minimum of 6 years experience in a clinical research environmentMinimum of 3 years experience reviewing and validating medical dataIn some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily Knowledge, Skills and Abilities:Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, Standard Operating Procedures and client expectationsExcellent understanding of pharmaceutical/clinical/medical terminologyExperience that demonstrates strong attention to detailExperience with interactive computer programsExcellent written and verbal communication skillsExcellent organizational and analytical problem-solving skillsAbility to work productively without direct supervisionHigh degree of confidentiality with medical records and client's proprietary dataDemonstrated working knowledge of Good Clinical Practices and applicable Standard Operating ProceduresExcellent customer focus and excellent interpersonal skillsProven flexibility and adaptabilityAbility to work in a team environment and independently as neededMust demonstrate good judgment in making decisionsMust be able to set timelines and commit to them or be able to negotiate schedule changes in response to project demandsAbility to travel to other locations as required or as business need dictatesStrong command of English language and grammarPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.Education and Experience:Bachelor's degree or certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)Minimum of 6 years experience in a clinical research environmentMinimum of 3 years experience reviewing and validating medical dataIn some cases, a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily Knowledge, Skills and Abilities:Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, Standard Operating Procedures and client expectationsExcellent understanding of pharmaceutical/clinical/medical terminologyExperience that demonstrates strong attention to detailExperience with interactive computer programsExcellent written and verbal communication skillsExcellent organizational and analytical problem-solving skillsAbility to work productively without direct supervisionHigh degree of confidentiality with medical records and client's proprietary dataDemonstrated working knowledge of Good Clinical Practices and applicable Standard Operating ProceduresExcellent customer focus and excellent interpersonal skillsProven flexibility and adaptabilityAbility to work in a team environment and independently as neededMust demonstrate good judgment in making decisionsMust be able to set timelines and commit to them or be able to negotiate schedule changes in response to project demandsAbility to travel to other locations as required or as business need dictatesStrong command of English language and grammarPharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.