Marinus Pharmaceuticals, Inc.

Clinical Trial Manager

Location
Villanova area
Posted
Mar 19, 2018
Required Education
Bachelors Degree
Position Type
Full time

We are seeking a Clinical Trial Manager to support our Postpartum Depression Trials.  PPD can affect a mother’s ability to care for her child and may negatively affect a child’s cognitive development. The most common medications prescribed to women who seek treatment for PPD are SSRI’s and SNRI’s, which have limited evidence of efficacy. There are currently no approved therapies to treat PPD.  Enrollment is on-going in our Phase 2 Magnolia Study, and in our Phase 2 Amaryllis Study.  Join the team that will affect the quality of life for women and their families.  We provide a very competitive benefits package and a dynamic team!

Clinical Trial Manager

The Clinical Trial Manager is responsible for supporting the Director of Clinical Operations in the operational management and oversight of clinical trials within the assigned clinical program.  The Clinical Trial Manager will report into a Director of Clinical Operations.  Manages the operational aspects of assigned clinical trials, including liaising with investigational sites, conducting on-site monitoring and/or co-monitoring visits, and managing external vendors/disciplines and contract Clinical Research Associates (CRAs).

Develops study specific tools and documents and provides overall direction for the clinical sites and study team members. Ensures that clinical trials are conducted according to the study protocol and in compliance with all applicable SOPs and regulatory guidelines.

Recommends and implements innovative process ideas to positively impact clinical trials management. Possesses the ability to work efficiently in a fast-paced environment.

Primary Responsibilities and Duties:

  • As applicable, liaise directly with sites on start-up documentation collection, review and release for drug shipment.
  • Assist to provide oversight of investigational sites to ensure accuracy of clinical safety event reporting, accuracy and validity of reported data, assistance with resolution of data queries, accuracy of drug accountability, review of clinical site study files to ensure compliance and other items as required
  • Assist to provide oversight of investigational sites to ensure accuracy of clinical safety event reporting, accuracy and validity of reported data, assistance with resolution of data queries, accuracy of drug accountability, review of clinical site study files to ensure compliance and other items as required
  • Assist with the identification of problems and resolve any issues to ensure the successful and timely completion of projects
  • Assist with the planning, coordinating and conduct of program kick-off meetings, investigator meetings, site trainings, data monitoring committee meetings and other meetings as required
  • Assist with the preparation, negotiation and management of site/vendor budget, contract and payments
  • Assist with the preparation, negotiation and management of site/vendor budget, contract and payments
  • Assist with the tracking of enrollment rates, receipt and review of completed eCRFs to ensure the efficient execution of a clinical trial
  • Assist with writing and/or review of all project-related documents including but not limited to: protocols and amendments, budgets and requests for proposal, change orders, informed consent, case report forms, monitoring plans, statistical analysis plans, data management plans, clinical study reports, study-specific training materials, reference binders and other documents as required
  • Assist with writing and/or review of all project-related documents including but not limited to: protocols and amendments, budgets and requests for proposal, change orders, informed consent, case report forms, monitoring plans, statistical analysis plans, data management plans, clinical study reports, study-specific training materials, reference binders and other documents as required
  • Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
  • Attend and participate in vendor and internal project team meetings to provide summaries of clinical study progress
  • Attend conferences and scientific meetings as required and foster and develop strong relationships with site investigators and key stakeholders within the broader patient community such as foundations and advocacy groups
  • Participate in the identification and recruitment of investigator sites and assist in the development of investigator/patient recruitment strategies and materials
  • Participate in the review of company SOPs and quality management plans
  • Performs job duties with minimal supervision and has a sound critical thinking and problem-solving skills.
  • Plan, coordinate and conduct clinical monitor training meetings including protocol training, therapeutic training and site visit training
  • Provide technical and scientific guidance to partnering CROs, investigator sites and other study personnel and service providers to ensure consistency in interpretation and exchange of scientific information as needed
  • Support the principal liaison with internal study team members, partnering CRO’s, investigator sites and other study personnel and service providers
  • Work with sites/CRO(s) on IRB/EC and associated regulatory authority submissions.

Qualifications/Experience:

  • Bachelor’s degree 
  • Will have up to 5 years trial management experience and at least 2-3 years on-site clinical monitoring experience
  • Will have strong interpersonal, public speaking and communication skills
  • Will have the ability to travel (national/international) ~25% or more depending on clinical phase and demands of the assigned study
  • Must be knowledgeable of U.S. regulatory requirements and ICH and GCP guidelines
  • Must demonstrate leadership and decision-making skills. Flexible with the ability to handle multiple tasks with competing priorities
  • Experience with Phase I-III trials is preferred but not required
  • Experience with conducting clinical trials in the US and global locations is preferred but not required
  • Experience in CNS or Epilepsy is preferred but not required

To learn more about our company please see our website

 http://www.marinuspharma.com/

 

If you would like to discuss this position, please forward your resume to

HR@Marinuspharma.com 

and attach your resume in word or a pdf document using this format:   last name, first initial PPD.   

 

Marinus is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.