Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Clinical Trials Manager - Remote

Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Reference: 26961
Closing Date: 05 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Clinical Trial Manager (CTM) provides operational expertise and leadership in the planning, implementation and management of clinical trials through all periods of trial conduct.  The CTM is responsible for quality and ‘on time’ delivery of clinical deliverables.  All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance.

Requirements:

Overview

The Clinical Trial Manager (CTM) provides operational expertise and leadership in the planning, implementation and management of clinical trials through all periods of trial conduct.  The CTM is responsible for quality and ‘on time’ delivery of clinical deliverables.  All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules and guidance.

 

Responsibilities

  • Serve as the primary clinical contact for both the Client and SynteractHCR project team members

  • Serve as the primary point of contact for the clinical study team. Provide leadership throughout and maintain effective communication at all times

  • Work in collaboration with SynteractHCR Project Management and functional project leads in the execution of clinical trials

  • Define and implement study-specific standards, goals and expectations for the clinical study team

  • Coordinate, facilitate, and, conduct training for clinical study teams as required. Address ongoing training needs throughout the study and ensure all trial-specific training is documented appropriately

  • Ensure completion of clinical activities within agreed timelines

  • Ensure adherence to the Clinical portion of the project budget; identify and consult with Project Management on clinical tasks that are out of scope

  • Oversee the quality and ensure compliance with project specific plans for all clinical deliverables; work with Project Management to identify and mitigate associated risks

  • Oversee site assignments and ensure clinical resources are continuously adequate

  • Participate in appropriate external study meetings, including both client and investigator meetings. Prepare and present as required

  • Coordinate and lead clinical meetings. Prepare agenda and minutes as required

  • Develop and maintain clinical study documents, templates, plans and manuals. These include, but are not limited to, the Clinical Monitoring Plan, Study Reference Manual and associated appendices

  • Develop, maintain and oversee trial specific tools to support the clinical operations team

  • Maintain oversight of site selection and activation activities. Ensure appropriate tracking throughout

  • Effectively interpret and report on clinical progress and associated metrics

  • Ensure applicable trial-related information is tracked and maintained in CTMS as required

  • Oversee the set-up and maintenance of the clinical portion of the trial master file (TMF)

  • Communicate with the Project manager and/or Line Manager as required, escalating issues of importance where appropriate

  • Track and review monitoring visit reports and ensure standards for monitoring and reporting are met; ensure appropriate and timely follow up on open action items

  • Maintain and review protocol deviation tracking, ensuring standards for reporting are met

  • Establish an effective and collaborative working relationship with external Vendors as appropriate, identifying both responsibilities and process

  • Provide input to clinical proposals, budgets and contracts

  • Support Business Development in preparing for and attending Bid Defense meetings

  • Contribute to the planning and conduct of feasibility studies

  • Conduct accompanied field assessment visits with CRAs as appropriate

Qualifications

 

Academic & Professional Qualifications:

  • Bachelor’s degree in a life science or related field of study OR equivalent combination of studies, nursing qualifications and/or work experience

  • 5+ years relevant clinical research experience, including monitoring experience

  • Experience in aspects of clinical study management, including the review of visit reports and the development of study-related documents

Skills & Experience:

  • In-depth working knowledge of current ICH-GCP guidelines and applicable regulations

  • Thorough knowledge of clinical research process

  • Strong communication skills including effective verbal, written and presentation skills; English + local language, if relevant

  • Demonstrated ability to lead, mentor and provide clinical guidance to team members

  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint

Travel Requirements:

  • This position requires the ability to travel 30-50%

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: Clinical Trials Manager - Remote

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

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.