Company: SynteractHCR Deutschland GmbH
Location: Morrisville, NC
Closing Date: 05 Dec 16
Type: Full Time
Salary (£): On Application
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.
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.
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
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
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.
SynteractHCR Deutschland GmbH
|Tel:||+49 89 12 66 80 0|
|Fax:||+49 89 12 66 80 2444|
|Website:||Visit Our Web Site|
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