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WHAT
IN
Medical Project Manager
Job
Parexel
US
-
Waltham,
Massachusetts
Job Code - 2392654
Position - Full Time
Job First Active on: Thursday, November 05, 2009
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JOB DESCRIPTION: Medical Project Manager
The Medical Project Manager will provide management, general oversight and direction for all Medical Services and Pharmacovigilance (PV) projects, including medical monitoring, clinical endpoint, data monitoring and clinical and post-marketing pharmacovigilance projects and activities. The MPM will also be responsible to provide input, advice and direction to resource planning and allocation, project team management, stakeholder liaison, strategic planning and reviews.
Key Accountabilities
The MPM will be responsible for management, general oversight and direction for all Medical Services and PV projects, including medical monitoring, clinical endpoint, data monitoring and clinical and post-marketing PV projects and activities. The MPM will also be responsible to provide input, advice and direction to resource planning and allocation, project team management, liaison with internal and external stakeholders, strategic planning and reviews.
In activities involving project management, the MPM will be either acting as the standalone Project Manager (PM) or as the Medical Functional Lead working with the overall PAREXEL PM, to ensure that projects run on time, on budget, and in accordance with client contract, SOPs, quality standards and regulatory guidelines.
Projects may involve the following tasks:
-Clinical trial safety management ' receipt, processing, databasing, follow-up and regulatory reporting of SAEs.
-Clinical trial medical monitoring ' receipt, processing and follow up of endpoints, lab alerts and waivers.
-Management of Data Monitoring Committees (DMCs) and Clinical Endpoint Committees (CECs): communication with client, team members, DMC and CEC consultants.
-Post-marketing PV - receipt, processing, databasing, follow-up and regulatory reporting of spontaneous adverse drug reactions (ADRs), conduct and review of literature searches, preparation and submission of PSURs.
-Any other activities as required by lifecycle drug safety services.
If the MPM will be acting as the standalone Project Manager (PM) the MPM Medical Services Europe will be responsible for the financial management /administration of the standalone projects according to Corporate Business Operating Procedures e.g.
-Monthly revenue recognition and forecast activities
-Invoicing according to contract -service and pass through cost (in cooperation with Project Analyst)
-Intercompany invoicing (in cooperation with Project Analyst)
-Monthly control/adjustment of time reported (in TIME)
-Project close out activities WW (in cooperation with Project Analyst)
-Provide project information to Project Analysts ' Medical Services Europe
-Maintenance of PAREXEL information databases (e.g. GXDB, PIP)
-First point of contact for the client for all financial related issues (e.g. CIS, reminders)
-Coordination/management of project team
In addition, the MPM will be responsible to provide input, advice and direction to resource planning and allocation, project team management, stakeholder liaison, strategic planning and reviews:
-Management, support, direction, coordination and planning for any medical and other PV related activities, including oversight of and contribution to PV consulting projects.
-Strategic input, including providing subject matter expertise in the planning and setup of PV projects, including costing, budgeting, resourcing, workflow and process design and analysis.
-Provide training and mentoring to junior MPMs and Drug Safety Staff.
-Timely contribution to, strategic input and review of information requests, proposals, and contracts as required.
-Liaise with internal (e.g. business operations, account management, PAREXEL Consulting) and external stakeholders (e.g. clients, third party vendors, health authorities).
-Represent Medical if and when required for internal and external matters.
-Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate.
-Contribute to Medical and PV resource planning and strategy.
-Contribute to the costing of Medical and PV projects, including the review of and improvement of performance metrics, costing tools.
-Attend and lead client meetings, and bid-defense meetings.
-Provide timely input and feedback to process improvement.
The MPM will be required to keep PV knowledge and knowledge of any other Medical service current as required by regulations, and to document competencies appropriately in the training documentation files.
Skills
-Excellent knowledge of drug safety and the drug development process
-Excellent knowledge of and ability to interpret and apply global safety and other relevant regulations
-Experience in data analysis, evaluation of safety data and the preparation of safety reports
-Experience with computer applications including database management and pharmacovigilance related computing systems
-Leadership skills ' ability to build effective project teams, ability to motivate others, delegation skills, drive and timely/quality decision-making
-Personal qualities ' ability to gain trust and confidence with a variety of clients as well as within PAREXEL, good learning ability, managerial courage, action oriented and resilience in a fast-paced and rapidly changing environment
-Business/Operational skills ' customer focus, commitment to quality management and problem solving
-Influencing skills ' negotiation and teamwork
-Effective communication skills ' provision of timely and accurate information to stakeholders and strong written and oral communication skills
-Advanced knowledge of business operating procedures (e.g. contract approval, revenues recognition, project close out)
-Advanced knowledge of the PAREXEL financial/information tools (e.g. PERFORM, Portal, TIME, PIP, GXDB)
-Basis knowledge of accounting (AP, AR)
-Advanced EXCEL, WORD skills
REQUIREMENTS - QUALIFICATIONS: Medical Project Manager
Education
-Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification
-Associates/diploma degree in any of the above with appropriate work experience
Language Skills
-Fluent English
Minimum Work Experience
-Considerable drug safety knowledge and experience
-Substantial experience of working in drug development and/or healthcare environment
PAREXEL is an Equal Opportunity Employer that develops strength through diversity. Please visit our web site at www.parexel.com.
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