Company

KCR

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Associate Director, Project Management (US)

City/voivodeship

Boston

Publication

2018-08-24

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Clinical Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ experienced Associate Director, Project Management.
The new incumbent shall take full accountability for international project and study program delivery on time, with quality and within planned budget, and also take the line management responsibility..
This is a permanent position based in one of the company’s Operational Hubs in Boston (US).
Location:  Boston (office-based/home-based)

The duties associated with the role include:
 
  • Hold accountability for ensuring all project deliverables are on time, within budget and with quality to meet customers' expectations as well as KCR's standards
  • Liaise with Sponsors, services providers and other major functions with the company to support milestone achievement and to manage study issues
  • Develop/adjust study delivery strategies
  • Provide overall coordination and management of clinical trials globally
  • Provide direction over technical, protocol-specific and operational aspects of assigned trials
  • Participate in bid defense preparations and conduct bid defense meetings in partnership with Business Development Department
  • Achieve project quality by identifying quality risks, responding to issues and /implementing appropriate corrective and preventative action plans
  • Ensure the financial success of project
  • Proactively reporting study progress, delays and risk, as well as associated action plans.
  • Report out to Head of Department on the assigned activities according to the requirements, timelines and realization of study budget.
  • Participate in Sponsor audits and Regulatory Authority inspections
Requirements:
 
  • University degree in life sciences or equivalent clinical research experience
  • At least 10 years clinical research experience including 6 years project management experience across multiple global studies
  • Excellent understanding of the global drug development process
  • In depth knowledge of applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Focused on project work, driving results based on set milestones, assuring compliance with applicable regulations and work schedules
  • Proven ability to deliver results to the appropriate quality and timeline metrics, monitoring/managing performance and providing feedback and coaching
  • Strong understanding of, and experience managing, contractual obligations and implications
  • Excellent communication and negotiation/influencing skills
  • Flexibility to work with different time zones
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.