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Job Details

Clinical Trial Manager - Remote

Company name
Synteract, Inc

Location
Morrisville, NC

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Clinical Trial Manager - Remote

Location:

Morrisville, NC

Job Id:

27443

# of Openings:

1

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. This role can be located in our Morrisville, NC or Carlsbad, CA offices, or home based anywhere in US. Role has potential to be hired at Sr. CTM level depending upon individual experience.

Responsibilities

Serve as the primary clinical contact for both the Client and Synteract 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 Synteract 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 the 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

Serve as Global CTM for international studies as necessary

Represent the clinical organization in the relevant Governance Committee(s) as necessary

Provide mentoring and/or oversight of less experienced CTMs and/or other members of the clinical department

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 3-5 years in a CTM or equivalent role

Demonstrated significant experience in the clinical management of studies

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

Well developed organizational skills in a complex and fast-paced environment

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

Work Arrangements:

This role can be located in our Carlsbad, CA or Morrisville, NC offices, or Home Based anywhere in the US.

Work is performed in a standard office environment with minimal exposure to health or safety hazards.

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.

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Company info

Synteract, Inc
Website : http://www.synteract.com

Company Profile

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