Project Manager - LSS - Gaithersburg, MD
Location: Gaithersburg Maryland
Description: SGS is employing Project Manager - LSS - Gaithersburg, MD right now, this vacancy will be placed in Maryland. For detail informations about this vacancy opportunity please give attention to these descriptions. Primary Responsibilities The Project Manager (PM) provides leadership to a cross-functional /multi-national team in the execution of the clinical research projects. H! e/she contributes to the pre-award process, the development of the study budget and related documents as well as the bid defense meeting, if applicable.
The PM develops and manages the overall study planning and implementation and is the primary liaison between the sponsor, the SGS project team, and the different vendors participating in the study throughout the life-cycle of the project. The PM performs general supervision of the project and liaises with the coordinating team member of the different departments involved in the execution of the project in order to ensure the assigned trial is conducted in accordance to the contract and in compliance with i) the applicable regulatory requirements, ii) the pre-defined procedures, iii) the applicable quality standards, and iv) the mutually accepted timelines.
It is the responsibility of the PM to manage the project as such that the sponsor's expectations are met within the constraints of the budget allotted t! o the project. The PM pro-actively works with project team mem! bers to identify potential issues that might impact the execution of the project and/or the budget in any way and provides contingencies to accommodate the needs of the assigned project. Reporting to Head of Project Management, USA Specific responsibilities Project Accountability:
- Serve as the main point of contact for the client and provide overall management of the assigned project(s) as such that the deliverables to the sponsor are met.
- Ensure compliance with the applicable SOPs, quality documents and guidelines, protocol and amendments (if applicable), written procedures and agreements with the sponsor.
- Maintain detailed project planning, update this planning on an ongoing basis and communicate changes to the project team and the sponsor
- Identify changes in resource needs during the lifecycle of the project and ensure elevation of any constraints to the respective department manager
- Identify issues that might delay the comple! tion of the project and work with the project team to provide recommendations / solutions to the sponsor
- Lead risk management activities by working with the project team to identify risks and implement risk mitigation strategies and contingencies
- Respond promptly and appropriately to study issues raised by sites, sponsors, monitors, members of the project team or study vendors
- Monitor performance metrics on an ongoing basis to ensure goals of the project are met and report project status updates to the sponsor and the appropriate SGS managers
- Ensure timelines and deliverables for Clinical Operations, Bio-analysis and Biometrics activities, if applicable, are agreed upon and adhered to.
- Ensure implementation of outside vendor /supplier procedures in compliance with the protocol and the trial requirements
- Ensure oversight of the performance of contract CRAs, partner CROs, and external vendors / suppliers to ensure contract! ed deliverables are met to budget, time and quality.
- Ensure He! alth Authorities submission/approval of all necessary documents is obtained prior to the start of the study in the respective country
- Ensure Institutional Review Board / Independent Ethics Committee (IRB/IEC) approval of all necessary documents is obtained prior to the trial initiation of each individual site.
- Coordinate the planning, preparation and conduct of the investigator meeting, if applicable
- Evaluate project performance on an ongoing basis and organize a lessons learned meeting at the end of the project in order to implement process or procedural improvements
- Review the Clinical Study Report
- Team management and communication
- Manage and develop trial documentation
- Sales and business development activities
- Budget and contract coordination
- Coach and train new project management
- Act as primary contact for audits
- Other duties as assigned. Profile Qualification / Education
- Minimum of 4-year University / College degree in science area or nursing)
- Equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a
- Fluent in English (written and spoken). Any other language is an asset.
- Good knowledge of MS Office and MS Project
- Good knowledge of GCP-ICH
- 5+ years of Project Management Experience
- CNS experience a must
- ER and/or ICU experience a plus but not mandatory
- Available for Immediate Hire
- Strong organizational skills to cope with multi-tasking which result in a goal-oriented approach without losing the attention to details.
- Ability to prioritize and delegate.
- Stress resistant and a strong team player with the ability to work independently without supervision.
- Good people management skills
- Strong presentation and writing skills
- Ability to adapt to changing situations focusing on the needs, goals and priorities of the organization.
- Willing to travel (domestic and international) as needed. Additional information - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required.
- This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
- SGS is an Equal Opportunity Employer.
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If you were eligible to this vacancy, please email us your resume, with salary ! requirements and a resume to SGS.
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This vacancy starts available on: Sat, 20 Oct 2012 04:52:42 GMT