Sr. CTM

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Apex Systems
Manager, Protocol, Systems
Full Time

Job Description

Senior Clinical Trial Manager, Clinical Operations 1171412

Job Scope & Purpose:

Our Cambridge-based Microbiome Therapy client is seeking an experienced Clinical Operations professional to join their growing team as a Sr. CTM. This role can be remote.

This role will need to independently organize and manage multiple clinical trial activities including facilitating cross-functional team meetings, managing vendors, and addressing protocol related questions. S/he would also be ensuring that study milestones are met and that the trial is completed in accordance with the protocol and within budget.

The Senior Clinical Trial Manager will function as a member of the clinical team and is responsible for management of all clinical aspects of sponsored clinical trials to ensure compliance with the Clinical Protocol, Standard Operating Procedures (SOPs), Good Clinical Practices and ICH Guidelines.

Primary Job Responsibilities:
  • Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Organize and facilitate/document study cross-functional team meetings
  • Setup and review study Trial Master File periodically for quality control measures
  • Review and provide input for reports and clinical documents such as informed consent, protocols, Investigator's Brochure, yearly updates to the regulatory authorities and status updates
  • Responsible for communication and escalation of study related risks and issues as required
  • Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs
  • Assist in the oversight of monitoring activities and site visits
  • May represent Clinical Operations in cross-functional initiatives
  • Manage and attend Investigator Meetings, conferences, and perform co-monitoring as needed
  • People management of junior staff as the team rapidly expands
  • Assist with interim and final report and data analysis of clinical trial results
  • Provide regular status updates of project progress
  • May support inspection readiness, audit preparation, or specific projects related to vendor management, training, and clinical team infrastructure

Primary Job Requirements::
  • Demonstrated computer skills including functional knowledge of Microsoft packages and ability to develop proficiency in technical systems and programs
  • Experience developing, reviewing, and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
  • Experience managing CROs, vendors, and/or clinical trial consultants
  • B.S. (or equivalent experience) and 4+ years of relevant work experience; candidate has to have worked as a CTM, preferably in a Sponsor environment

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Code: ClinOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1171412
Originally Posted : 3 months ago

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