Clinical Project Managers
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Our Pfizer Clinical Research Unit (PCRU) in Brussels is a state-of-the-art research facility with sixty inpatient beds dedicated to early clinical trials (Phase 1 & 2a studies).
1. Responsible for study/project management within the unit including study scheduling, protocol planning(start up activity) and will be the primary contact for the project teams responsible for the compound/project - form the time of the Study/project Document is Drafted until the data base/project is locked.
* Serves as primary liaison/point of contact for the Core Project Teams/Pfizer Clinical Research Unit (PCRU)
* Create and ensure adherence to study timelines
* Supervises initiation and monitoring of all study activities
* Primary point of contact for on study decisions related to the protocol, data collection and volunteer activities
* Partners with different PCRU departments
* Maintains accuracy, accessibility and confidentiality of all volunteer records and reports
* Monitors and summarizes clinical data
* Evaluates and may identify new equipment/technologies/vendors
* Lead the data management activities for assigned protocols
* Initiate Inform Consent Document for Ethics Comitee submission
2. Responsible for ensuring clinical trials are conducted in accordance with scientific, medical, and ethical principles, and within regulatory requirements/guidelines. Responsible for volunteer safety and accurate interpretation and execution of research protocols including multiple study activities
* Contributes to the clinical study components with respect to time, operational feasibility, and study-level PCRU resources required to deliver individual studies against the development plan (part of the study budget)
* Assesses impact of technologies required to deliver clinical trials and incorporates the development of these technologies into the clinical studies to ensure conduct and data collection suitable for purpose
* Provides support for Methodology/Mechanistical sudies as appropriate
* Partners with Core Project Teams to provide study schedule and budget information to enable project management
* Identifies performance/quality issues to develop appropriate remediation plan
* Identifies and escalates system or process issues hindering delivery
* Overseas the creation and detailing of study activity/source documents.
* Supervises/Monitor the initiation and quality control of all study related activities for assigned protocols
3. Initiates and manages all operational study activities:
* Provides critical operational and feasibility input to study design
* Contributes to the protocol development
* Aligns and influences study level operational strategies across programs and partner lines
* Provides critical assessment of strategic partner and vendor proposals to ensure study success
* Ensures appropriate level of oversight is maintained utilizing escalation plans and providing resolution to issues at the study level
* Forecasts site level clinical trial budget
* Works proactively with other functions and strategic partners for timely delivery of quality data
* Oversees the overall execution of clinical studies
* Participates in study meeting with relevant partners for operational alignment
* Communicates opportunities and risks to the Core Project Teams for integration in risk management plans
* Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
* Anticipates potential problems within a clinical trial and creates contingency plans accordingly
* Mentor and coach other clinic staff as needed
* Initiate general staff training activities
* Lead data management: Manages all queries specific to subject data collection & Supports in EDCMS setup activities.
* May represent the unit on Global initiatives (Global SOP's, process improvement teams, other activities as they present themselves) as they are the subject matter experts in the Unit.
* May Lead PCRU teams in accomplishing business needs and resolving issues
* May represent the PCRU as a subject matter expert for internal/external resource (provide support to external center, etc.)
* Participate in study and staff scheduling for assigned protocols, as appropriate
* May participate in study related data collection activities to ensure business continuity.
* Oversee creation and detailing of study activity documents for staff & volunteer use
* Minimum of BA/BS in a biomedical discipline or equivalent education/training is required
* At least 5 years relevant experience in clinical research and drug development with clinical operations experience. Preferably with first Experience in early drug development (Phase I and IIa)
* Substantial clinical operations and pharmaceutical industry experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues.
* Experience in Project Management and leadership of matrix teams is essential
* Fluent in speaking and reading English. Preferably, your second language would be French or Dutch (for PCRU BR)
* Drug development experience including familiarity with: Clinical study management and monitoring, Project/process management, Data management, Clinical & regulatory processes, Regulatory submissions, Budget / expense management, Experience of Vendor Management, Scientific excellence, Administrative excellence, Systems technology
* Initiating and Implementing Change: Innovation, Learning Organization, Flexibility and Resilience, Courage with Decisiveness to Act, Problem Solving, Positive approach, forward thinking, challenge the status quo
* Matrix leadership skills: Influencing, Collaborative, supportive, Networking and Alliance Building, Personal Leadership, Team work, Communication, Negotiation, Decisive and assertive, Change agile, Able to deal with ambiguity
* Ease in using office tools suite (xls, word,etc…)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Belgium - Brussels