Pfizer #2# Clinical Project Managers in Brussels, Belgium

ROLE SUMMARY

  • Initiates and manages all operational study/project activities & serves as Primary point of contact for the Core Project teams.

  • Translates protocol/project strategies from a concept into an executable study/project

  • Focuses upon the operational integrity and feasibility of individual studies utilizing a variety of resource solutions to ensure the most effective, efficient, and high quality study/project is designed and executed

  • Participates in and influences the operational strategy for study/project delivery including milestone deliverables to optimize use of time, cost and resources

  • Participates in the identification, assessment and mitigation of risks at the study level

  • Maintains continuous communication between partner lines, strategic partners, Pfizer Clinical Research Units (PCRU), contractors and vendors

  • Optimize Operational Control and Effectiveness

  • Assures close partnership with study investigators to assure successful study delivery and high quality data

  • Fosters positive community attitudes and volunteer trust through professional behavior and ongoing communication.

ROLE RESPONSIBILITIES 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

QUALIFICATIONS

  • 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.