Clinical Trial Manager

Location
Jersey City, NJ, USA
Posted
Aug 29, 2020
Ref
169884
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates (MTEM) is a clinical stage biopharmaceutical company focused on the development of a next generation immunotoxin platform technology called Engineered Toxin Bodies (ETB) in oncology. MTEM's lead program, MT-3724, is in clinical development for non-Hodgkin's lymphoma and additional pipeline drug candidates are being advanced toward clinical development for a variety of cancers. For more information, please visit MTEM's website at www.mtem.com.

Position Overview:

Molecular Templates is seeking an experienced and highly motivated professional to be an integral part of the Company's clinical development team. The Clinical Trial Manager will act as primary site contact and site manager throughout all phases of clinical research studies, taking responsibility for implementation and oversight of studies, monitoring the compliance with protocols and providing point of contact for investigational sites and CRO personnel. Qualified candidates must possess comprehensive knowledge of clinical trial conduct in accordance with ICH/GCP and other related regulations or guidelines; excellent organizational, project management and time management skills. Further, qualified candidates must be able to function independently, exercise good judgement, work in a fast-paced environment and travel (up to 20%).

Job Responsibilities will include:
  • Provide operational oversight for clinical studies in collaboration with all members of the Clinical Operations study team.
  • Identify potential Investigators and clinical sites; and contribute to the site selection and site activation process.
  • Responsible for operational delivery of MTEM-sponsored clinical protocols and amendments.
  • Responsible for vendor management (eg. CROs, IRT/IVRS, central imaging and central labs). Among other responsibilities, this would include: Participate with and facilitate CRO/vendor selection process for outsourced activities, manage CRO interactions, including sponsor oversight of operational function activities; work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Responsible for the set-up and maintenance of IRT/IVRS and central lab vendors.
  • Responsible for delivery of clinical trial supplies in collaboration with CRO and clinical supply manager.
  • Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level, including risk management and mitigation. Track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.
  • Provide input into CRF design process and implementation and setup of EDC systems. Continuous review of data entry for integrity, correctness, timeliness, in collaboration with Clinical Development and the CRO.
  • Create, update, and implement appropriate innovative and best-in-class processes and SOPs related to clinical study development and execution and reporting, in collaboration with Clinical Development and Quality Assurance.
  • Contribute to the project plan and monitor related budgets and resource allocation in collaboration with the Director of Clinical Operations.
  • Ensure resolution of identified issues during clinical data and protocol deviation reviews in collaboration with Investigational sites and the clinical study team.
  • Travel up to 20%.

Qualifications:
  • Bachelor of Sciences degree in Life Sciences, required.
  • 5+ years of experience as clinical trial manager in pharmaceutical industry or CRO with on-site monitoring responsibilities, preferably in oncology.
  • Global experience is required.
  • Comprehensive practical knowledge of the clinical trial development conduct and reporting in accordance with ICH/GCP and other related regulations or guidelines.
  • Awareness of global regulatory and pharmacovigilance environments.
  • Ability to lead the cross-functional study team and experience in coordinating collaboration with investigative centers, clinical staff and vendors is required.
  • Excellent written and verbal communication skills in English is required.
  • Excellent organizational, project management and time management skills.
  • Quality-oriented with excellent attention to detail.
  • Proficiency with all office suite tools (MS Word, Excel, PPT, Visio).
  • Ability to function independently and exercise good judgement.
  • Ability to work in a fast-paced environment.
  • Ability to drive and willingness to travel for study monitoring and auditing (up to 20%).

Reporting Structure:

This position has no supervisory responsibilities. This position reports to Director of Clinical Operations.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com