Marinus Pharmaceuticals, Inc.

Clinical Trial Managers

Location
Villanova Area
Posted
Jun 16, 2018
Required Education
Bachelors Degree
Position Type
Full time

Clinical Trial Manager/Senior Clinical Trial Manager 

Do you want to make a difference?

At Marinus, we are bringing hope to patients by developing new treatments to improve the lives of patients and families affected by epilepsy and neuropsychiatric disorders.  We are comprised of a team of highly qualified individuals committed to developing new therapies for CNS disorders and we are passionate about making a positive difference in the lives of the patients we serve.

We are growing and seeking new team members

 We have multiple clinical programs and are expanding our clinical operations group.  We are seeking Clinical Trial Managers to support our trials in Pediatric Orphan Indications and Postpartum Depression.  We are in the process of initiating a Phase 3 global study in children with CDKL5 deficiency disorder, a rare genetic epilepsy with no approved therapies. We have studied other disorders that affect pediatric patients such as PCDH19 related epilepsy, Lennox Gastaut Syndrome, and Fragile-X Syndrome, some of which we may consider further studying in the future.

We are currently enrolling patients in our two Phase 2 clinical trials in women with postpartum depression – The Magnoia and Amaryllis Studies.  Post-Partum Depression can affect a mother’s ability to care for her child and 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.

We provide a very competitive compensation and benefits package.

To learn more about our company please see our website 

Attach your resume in word or a pdf using this format: last name, first initial CTM

Position Summary:

Manages the operational aspects of assigned clinical trials, including liaising with investigational sites, conducting on-site monitoring and/or co-monitoring visits, and managing internal and external vendors/disciplines Clinical Research Organizations.

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
  • 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 and CTAs
  • 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:

  • Bachelor’s degree required
  • 3-5 years clinical trial management experience, phase 1-3 trials, 5-7 in pharmaceutical industry
  • experience with CNS clinical trials preferred
  • Travel requirements: variable: ~25%

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.