Marinus Pharmaceuticals, Inc.

Clinical Trial Manager

Location
Villanova area
Posted
Mar 19, 2018
Ref
PPD
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 we are initiating 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

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 virtual environment.

Primary Responsibilities and Duties:

  • Conducts and/or oversees all aspects required for selecting, initiating, monitoring and closing investigational sites in accordance with all applicable SOPs and GCP/ICH requirements.
  • Serves as a primary contact for internal clinical monitoring study team members, external vendors and clinical sites.
  • Participates in weekly conference calls with sponsor.
  • Manages and executes project management (maintains integrated timelines with all discipline deliverables), monitoring, site management, trial master files, and clinical research associate performance.
  • Assists in the preparation of clinical trial documents, including study protocols, amendments, model ICFs, laboratory manuals, CRF completion guidelines, study specific instructions, etc.
  • Provides timely and accurate information to Management for project level tracking.
  • Participates in evaluating investigational drug (IP) supply requirements and manages the logistical aspects of distributing supplies to the investigational sites.
  • Coordinates investigator meetings and develops presentation materials.
  • Conducts weekly team (interdisciplinary) meetings.
  • Manages CRAs
  • Routinely reviews study data and progress of EDC entry; works with data management and clinical sites to resolve data discrepancies. This includes reviewing primary, secondary and safety endpoints for inconsistency, irregularities, and/or signals.
  • Identifies program/clinical trial risks; proactively suggests and implements mitigation strategies.
  • Participates in the management of vendors to get deliverables delivered on-time and on-budget.
  • Participates in the preparation and finalization of company SOPs as necessary.
  • Performs job duties with minimal supervision and has a sound critical thinking and problem-solving skills.


Qualifications/Experience:
 

  • 5-10 years trial management experience, phase 2-3 trials
  • Experience with CNS clinical trials preferred
  • Experience with Women’s Health highly valued
  • Travel requirements: variable: ~25%
  • Bachelor’s degree

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@Marinus.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.