senior/principal Clinical review specPPD

Summarized Purpose
A Senior Clinical Review Specialist reviews patient data in accordance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs), and Data Validation Manuals (DVMs). Liaisons with colleagues in other functional groups as required, and communicate with management for all data review activities within their allocated studies.
A Principal Clinical Review Specialist is a core team member with expert-level knowledge, responsible for performing quality and timely reviews consistent with requirements defined by procedural and project-specific Data Validation Manuals (DVM).
Essential Functions
Senior Clinical Review Specialist
Reads and understands project protocols and Data Validation Manuals.
Reviews patient data in accordance with the Manual Data review Plan in the DVM.
Identifies data issues and works with the PPD team and study sites to resolve them.
Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget, and on time.
Provides support, guidance, and direction on clinical data review to the CDM project team including consultation related to Listing Review and related sections of the DVM.
Provides clinical review training to all CDM staff performing clinical review activities.
Participates in the development and implementation of processes, procedures, and training for the data management function, as directed.
Principal Clinical Review Specialist
Reads and understands project protocols and Data Validation Manuals.
Reviews patient data in accordance with the Manual Data Review Plan in the DVM and Client expectations.
Identifies data issues and works with the PPD team to resolve them, using creative thinking while maximizing efficiency to ensure data accuracy and quality expectations within budget and timelines.
Provides support, guidance, and direction on clinical data review to the CDM project team related to the listing review, applicable sections of the DVM, study metrics, utilization, and resourcing.
Liaises effectively with colleagues in other functional groups, and provides support to the clinical data team leads by attending project and client team meetings when required.
Provides mentoring to serve as a role model and resource to the clinical listing review team.
Collaborates with Alliance Partners to ensure seamless functionality across multiple studies, while managing the individual studies from a metrics perspective and supporting their study leads.
Qualifications
Education and Experience
Bachelor's degree in any Life Sciences / allied healthcare courses
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years').
In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, and Abilities:
Senior Clinical Review Specialist
Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs, and client expectations
Excellent understanding of pharmaceutical/clinical/medical terminology
Ability to use interactive computer programs
Excellent written and verbal communication skills with a strong command of the English language and grammar
Excellent organizational, analytical/ problem-solving skills and good attention to detail
Ability to work productively without direct supervision
High degree of confidentiality with medical records and client's proprietary data
Excellent customer focus and interpersonal skills
Ability to work in a team environment and independently as needed
Ability to set timelines and commit to them or be able to negotiate schedule changes in response to project demands
Principal Clinical Review Specialist
Ability to effectively apply knowledge and skills in a highly organized fashion utilizing adherence to regulatory guidelines, SOPs, and client expectations
Excellent understanding of pharmaceutical/clinical/medical terminology
Ability to use interactive computer programs
Excellent customer focus and excellent interpersonal skills
Proven flexibility and adaptability when working in a team and independently using excellent judgment in making decisions
PPD

Taguig City, Metro Manila
Permanent
Full-time