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Job Details

Senior Project Director

Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Reference: 27392
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Senior Project Director (SPD) is responsible for the overall coordination and management of clinical trials from start up through close out activities according to contractual time, quality/ cost parameters.  The SPD leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPD is accountable for ensuring that all project deliverables meet the client/contract...

Requirements:

Overview

The Senior Project Director (SPD) is responsible for the overall coordination and management of clinical trials from start up through close out activities according to contractual time, quality/ cost parameters.  The SPD leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPD is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction.

 

Responsibilities

  • Primary interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials. 
  • Assigned to manage a full range of projects; with preference given to international complex, multi-service (e.g., Clinical, Data Management, Biostatistics etc.) to full service, large scale programs.  May also be assigned to manage a client portfolio, with numerous projects managed by PM staff.  This also includes providing leadership/coaching/mentoring to the PM staff assisting on the client’s projects. 
  • Attend and present at client bid defense meetings.
  • Prepares proposals, budgets and addendums.
  • Represents Project Management on company-wide project teams.
  • Interacts with clients and company vendors to ensure that all contractual obligations are met.
  • Identifies potential bottlenecks and/or delays; develops and executes contingency plans in order to keep the project on schedule. 
  • Ensures adequate resource requirements.
  • Coordinates initial client meeting identifying project objectives.
  • Develops Project Management Plan to include timeline and milestones.
  • Coordinates Project Team Meetings, including development of meeting agendas and minutes.
  • Coordinates study specific training and other requirements for internal and external staff, as appropriate.
  • Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests.  Interacts with clients and vendors to ensure that all contractual obligations are met.
  • Interacts with company departments relating to project finances and information technology through the use and development of specific tracking and invoicing procedures.
  • Manages budget throughout the duration of the project and develops out of scope documentation and costs.
  • Manages the project trial master files.
  • May participate with company senior management in marketing and business development activities including professional meetings, trade shows, seminars and client capabilities meetings.
  • Contributes and participates in the analysis of departmental resource requirements.
  • Identifies and assists in departmental training requirements including internal and external operations and project manager mentor programs.
  • Contributes to the development and revision of Standard Operating Procedures (SOPs) and departmental policies.
  • May participate in the analysis and development of Project Management Department budgets.

Qualifications

Academic & Professional Qualifications:

  • Bachelor  / Master degree, in a related field of study and a minimum of 12 years applicable industry experience or equivalent combination of education and experience.
  • At least 8 years of experience as a PM within a CRO is required.
  • Oncology therapeutic experience required.
  • Doctoral degree is an asset.

Skills & Experience:

  • An excellent understanding of project management techniques.
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Excellent proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer
  • Effective verbal and writing skills; English + local language, if relevant.

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.

 


Apply for this job: Senior Project Director

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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