Job Description:
For over 25 years PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, we supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. We have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world. For more information about PAREXEL International visit www.PAREXEL.com .

Working independently and reliably showing a high level of ownership, also analytically minded with a strong focus on detail and committed to quality deliverables the Project Specialist collects and analyzes operational information of various sources including web based IT to present high level trends and conclusions to the Project Leader thus facilitating the project planning and decision taking process. As a strong team player the Project Specialist is able to communicate with various internal and external functions.

Key Accountabilities
-In general provide internal support to Project Leader as a project resource supporting internal systems and systems set-up but also executing day-to-day data analysis of the operational study status (planned versus current) and reporting activities.
-Prepare draft project plan including all sub plans (Communication plan, Risk Management plan, MSP, WSOP listing, Quality plan, etc.) for team discussion before Kick-off meeting,
-Develop and maintain Central Files Maintenance Plan (CFMP) in co-operation with Project Leader and project team. Support implementation according to the CFMP and oversee quality checks according to the plan.
-Prepare project documents and status reports for Project Leader.
-Prepare study recruitment plan in co-operation with SMO (Site Management Organization) which outlines key recruitment challenges for the trial and corresponding strategies to meet the milestone. Monitor compliance to the plan and report status to Project Leader.
-Responsible for assigned tool management including set up and maintenance of the recruitment planning tool (SPARC) in co-operation with SMO; Maintain investigator /supplier portal.
-Initiate, set-up and maintain Management Systems on a regular basis (GXDB, CTMS, PMED, other systems as required )
-Develop routine Client Report format with Functional Leads using standard reports where possible. May be involved with ad hoc client requests for reporting.
-Arrange project related training for project team members under the direction of the Project Leader and maintain project specific trainings overview and records.
-Oversee implementation of Quality Plan, perform Project Management related quality checks on the study according to Quality Plan and in close co-operation with Project Leader (e.g. Study Manual, CRF completion guidelines).
-Support Project Leader in identifying, implementing, reviewing and up-dating project specific operational performance metrics.
-Support Project Leader in appropriate selection of third party suppliers. Manage internal procurement process, ensuring that appropriate Scope of Work documents and Purchase Requisitions are in place
-Work with Project Leader and Project Analyst to develop 'what if' scenarios to ensure pro-active decisions and solutions.
-Document Lessons Learned and post in Lessons Learned database.
-Conduct project close out in management systems at end of project (GXDB, CTMS, PMED, and other systems as required).
-Support the proposal process by developing high level project plans (e.g. MSPs) for proposals.
-Ensure SAE reporting process and plan has been developed by the Medical Lead or relevant client contacts.
-May communicate with the client on specific items as directed by the Project Leader.
-Manage the project resourcing ' resource requests.

Skills
-Excellent interpersonal, verbal and written communication skills
-Client focused approach to work
-A flexible attitude with respect to work assignments and new learning
-Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
-Proficient in use of web based IT systems and MS Excel, PowerPoint, MS Project and Word.
-Analytical mind with attention to detail.
-Proficient in local language and profound working knowledge of the English language
-Comfortable with working in a matrix environment and being a conversant team player.
-Willingness to travel.

Education
-Minimal a Bachelor's degree or equivalent in a science related field, with an advanced degree desirable
-or sufficient, relevant job experience
-or another relevant education

Minimum Work Experience
-Proven relevant experience in healthcare, clinical research, project management or contract research organization.

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