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Job Details

Senior Clinical Project Manager

Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Reference: 27155
Closing Date: 18 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Senior Clinical Project Manager 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 SPM leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPM is accountable for ensuring that all project deliverables meet the...

Requirements:

Overview

The Senior Clinical Project Manager 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 SPM leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPM 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 the full range of projects; from the small limited in scope projects (e.g., data management, etc) to the full service, large scale, complex programs.
  • Attend and present at client bid defense meetings.
  • Prepares proposals, budgets and contracts.
  • 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.
  • Contributes to the revision of Standard Operating Procedures, guidelines, and departmental policies.
  • Manages the project trial master files.
  • Produces periodic reports. 
  • May identify and assist in departmental training requirements including internal and external operations and project manager mentor programs.
  • Ensures knowledge of clinical research, clinical therapeutics and regulatory issues, is current through review of journal articles and attendance of relevant professional association meetings.

Qualifications

Academic & Professional Qualifications:

  • Bachelor  / Master degree, in a related field of study and a minimum of 5 years applicable industry experience or equivalent combination of education and experience.
  • At least 3 years of experience as a PM is required.
  • Direct experience in conducting large scale full-service clinical trials is a must.

Skills & Experience:

  • A good understanding of project management techniques.
  • Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
  • 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

SynteractHCR 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.

 

SynteractHCR’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 SynteractHCR 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 Clinical Project Manager

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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