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26 days old

Director Project Management and Site Management APAC

WIRB-Copernicus Group (WCG)
Tokyo, Japan

General Information

Location: Tokyo, Japan

Organization: Medavante-Prophase, Inc

Job Type: Full Time - Regular

Description and Requirements

The Associate Director, Project Management, in our Tokyo office, is responsible for helping Project Management to establish and manage the consistent application of processes for project planning, specification and support.  The Associate Director is responsible for the day-to-day management of client projects and ensures that projects are delivered on time, within budget, and according to customer expectations.

The Associate Director, Project Management is responsible for providing leadership and oversight to Regional Site Management staff. They ensure an effective partnership with investigative research sites and sponsor representatives. The Associate Director, Project Management ensures that the team is responsive, accountable and issues are responded to in a timely manner and resolved to an acceptable point.  The role will collaborate with internal departments to ensure that services are executed.

EDUCATION REQUIREMENTS: 
Bachelors degree in related field and/or 5+ years related experience and/or training in a clinical project management environment (e.g., CRO,  pharmaceutical company, or other centralized service provider used in clinical studies) or the equivalent combination of education, skills and experience to perform the job.

QUALIFICATIONS/EXPERIENCE: 
5+ years supervisory experience preferred.
Knowledge of project management software tools and management techniques.
Possess demonstrated experience in developing complete project plans and executing the management and implementation of those plans on time and within budget.
Must have firsthand experience with all stages of the project life-cycle, from requirements gathering to release.
Ability to function effectively in a fast-paced environment and manage multiple projects simultaneously.
Experience working with technical solutions for Clinical Trials.
Experience working with psychiatric (e.g. depressions, anxiety) and/or neurocognition (e.g. Alzheimers disease) indications preferred.
Knowledge of IRB regulations and submissions (informed consent, etc). and Good Clinical Practice (GCP).
Demonstrate leadership skills and ability to manage, motivate, and integrate a team.
Excellent problem solving/decision making skills.
Proven project management experience at senior level.
Outstanding written and oral communication skills.
Excellent organizational skills.
Demonstrate negotiation skills.
Excellent interpersonal skills. Ability to lead through influencing and negotiating.
Ability to multi-process, delegate project tasks.
Proficient knowledge of MS Office, specifically Word, Excel, Access and PowerPoint as well as Adobe, Visio and MS Project and the ability to produce detailed reports and presentations using these tools.

ESSENTIAL DUTIES/RESPONSIBILITIES: 
Provides leadership in the delivery of services to clients, reviews work produced by project teams, and ensures that staff fulfills their responsibilities in accordance with project contracts and Company policies, procedures and SOPs.
Develop and manage department budget.
Possess a thorough understanding of specific aspects of work supervised and practical application to problems and situations ordinarily encountered.
Experience in strategic analysis, developing project plans, budgeting, scheduling, risk management, resource allocation, and scope management.
Lead kickoff, design, status, and other project related meetings with cross-functional teams and project stakeholders at all levels.
Present study services at client meetings, such as at Study Monitor Meetings, Investigator Meetings, and project initiation (kick-off) meetings.
Closely manage the entire project life cycle. Identify and track issues, risks, dependencies, efficiencies, and critical path objectives.
As part of project status tracking and reporting, continuously assess project risk factors and recommend appropriate courses of action to mitigate.
Provide timely and audience-specific status reports in support of defined metrics to senior management and other key stakeholders.
Manages site management activities between Project Management and the investigative research sites.  This includes ensuring the set-up, training, and follow-up on operational questions, basic technical troubleshooting, data entry management and patient safety issues are addressed appropriately. 
Serves as a subject matter expert on MA-PP systems to support MedAvante clinicians, investigative sites and project activities.
Monitor study-specific trial management tools/systems, ensuring appropriate use to trial management tools/systems and taking appropriate corrective action when needed. 
Attend investigator meetings, KOMs, project team meetings and teleconferences, as needed, representing site management team. 

About Us:
MedAvante-ProPhase, a subsidiary of WIRB-Copernicus Group (WCG) was founded in 2002 with the goal of helping to bring better drug therapies to market through smarter, faster clinical trials. With this goal in mind, MedAvante set out to solve one of Pharmas most intractable problems: the bias and variability that cause failed or inconclusive trials for Central Nervous System (CNS) therapies. A few years later, MedAvante experts pioneered Central Ratings and introduced the concept of Central Review utilizing their groundbreaking Virgil eSource solution.

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Posted: 2021-02-01 Expires: 2021-03-04

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Director Project Management and Site Management APAC

WIRB-Copernicus Group (WCG)
Tokyo, Japan

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