The Clinical Development and Operations (CD&O) Clinician is accountable for the medical & scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high quality clinical trials, employing quantitative design principles (including MIDD), and clinical best practices to deliver both clinical and operational excellence. S/he is responsible for effective execution of studies and works in close partnership with Clinical Operations team members. The CD&O Clinician is accountable for timely delivery of a quality protocol, clinical execution of clinical trials and supports appropriate interpretation and communication of clinical trial data. The CD&O Clinician maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues through timely, diligent clinical data, safety and protocol deviation review. The CD&O Clinician will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.
- Provides CD&O input to support development of the protocol design document.
- Leads or supports development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant /site engagement and which minimize the likelihood of amendments or quality issues.
- Partners with Category Clinical function in governance review and approval process.
- Provides clinical input to the DORA process to ensure application of data standards, optimized data collection and both timely and thorough review of data through the use of clinical data review best practice.
- Responsible for providing CD&O clinical input to SAP, TLFs and BDR.
- Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
- Provides clinical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.
- Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes, Inputs to, reviews and approves, Risk Management and Safety Review Plan.
- Ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead etc) to develop and implement any risk mitigations.
- Reviews and approves country selection, develops site selection criteria and ensures protocol specific training. Approves investigator meeting plans.
- Serves as the primary contact with external investigators and internal study team for questions relating to clinical aspects of protocol.
- Reviews, reports and manages protocol deviations and approves protocol amendments.
- Reviews patient level and cumulative data per the data review plan across one or more studies.
- Reviews safety data, SAE reports, TME's, DME's and ensures clinical documents (eg ICD) are updated as required.
- Tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
- Ensures TMF compliance for CD&O clinical documents.
- Inputs and reviews the Clinical Study Report including the review of narratives.
- Responsible for supporting disclosure of safety and efficacy data and trial conclusions.
- Contributes to primary publication of clinical trial results.
- Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection.
- May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.
- May support responsible colleagues with the development of responses to regulatory queries and audit/inspection findings and Clinical Trial Applications (CTAs).
- Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
- BASIC QUALIFICATIONS :
- Education: BA/BS or equivalent qualification required
- PREFERRED QUALIFICATIONS :
- Experience: 4+ years of experience and track record of success in biopharmaceutical industry in clinical research and development. Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management. Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer. Demonstrated experience managing and training large teams in clinical development. Demonstrated experience in designing and launching large teams preferred Competency Requirements:
- Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues. Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team.
- Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results. Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Last Date to Apply for Job: November 1st, 2021
Eligible for Employee Referral Bonus: YES
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