Senior Manager, Clinical Research Support

Organization
The Jackson Laboratory for Genomic Medicine
Job Location
263 Farmington Avenue
Farmington, CT 06032
Job Description

Senior Manager, JAX-GM Clinical Research Support        

The Jackson Laboratory for Genomic Medicine (JAX-GM) in Farmington, CT is seeking a Senior Manager, Clinical Research Support. This role is responsible to the JAX-GM Site Director for serving in a key position in JAX-GM’s efforts to obtain and manage external grant, collaboration and contract funding that supports the clinical and translational research and service components of JAX-GM’s mission, goals, and objectives.  Responsible for 1) all clinical research development and clinical affairs operations activities; 2) developing and implementing the clinical research strategies through functional interaction with the research team and other senior management; 3) coordinating with the Office of Sponsored Program (OSP) in all aspects of project administration of clinical research projects and clinical trials including the review of all proposals, budgets and contracts and tracking of all milestones and timelines; 4) the development of study related documents and overall direction of the clinical site(s) and 5) assuring compliance with the protocol and all regulatory guidelines. 

Responsibilities:

  • Provides support for faculty in preparing clinical research proposals for external and internal funding competition by designing, writing, implementing, and monitoring clinical research and IRB protocols.
  • Management and oversight of all clinical research and study activities.
  • Participates in regulatory strategy and matters especially as they pertain to clinical research and development activities, in close collaboration with OSP.
  • Oversees clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment.
  • Establishes and approves (with outside vendor, Executive team, biostatistics group) scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
  • Oversees data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, white papers and assist with manuscript preparation.
  • Creates and directs clinical program/project-related advisory committees as needed, data and safety monitory board and/or expert consultants.
  • Guides development of in-house clinical operations SOPs, guidelines and systems.
  • Ensures that institutional policies, laws and regulations regarding sponsored research support are proactively addressed and adhered to.
  • Travels to clinical sites when needed for site recruitment and review.

 

Requirements

 

  • MS in Research Administration, Bioscience or relevant field; Ph.D. in Bioscience preferred
  • Minimum of five years’ experience in management of all aspects of clinical  research in a scientific and/or clinical environment with knowledge of GCP, IRB, IBC, clinical trial conduct, clinical data interpretation, FDA and international regulations, clinical study design and documentation.
  • Experience with grant policies and procedures, and working knowledge of federal regulatory environment preferred.
  • Demonstrated leadership skills in assembling and managing a large and multi-disciplinary project team.
  • Demonstrated effective project management skills.
  • Demonstrated collaborative effectiveness.
  • Excellent verbal and written communication skills.
  • Ability to work under multiple deadlines.
  • Strong interpersonal skills and the ability to interface with institutional faculty and administrators required.
  • Strong organizational skills with ability to prioritize and manage large volumes of work, especially as related to collection and communication of complex information.
  • Ability to work independently with minimal supervision.

 

 

How to Apply

Please forward a copver letter and CV to www.jax.org/careers, requisition #4703.

About Our Organization

The Jackson Laboratory is an independent, nonprofit biomedical research institution based in Bar Harbor, Maine, with a facility in Sacramento, Calif., and a new genomic medicine institute in Farmington, Conn. We employ more than 200 Ph.D. scientists and a total of more than 1,400 employees. In 2011 and 2012, researchers voted The Jackson Laboratory among the world’s top 15 “Best Places to Work in Academia” in a poll conducted by The Scientist, a magazine for people working in the life sciences. The Laboratory draws on an 83-year reputation for excellence in mammalian genetics, built on the groundbreaking discoveries of its own researchers and on the development and global distribution of the most diverse collection of genetically unique mouse strains in the world. The Jackson Laboratory is a National Cancer Institute – designated cancer center. Our research covers a broad range of genetic disorders, including cancer, diabetes, neuromuscular and neurodegenerative disorders, autoimmune disorders, and conditions related to reproduction, development and aging. The Laboratory’s mission is to discover the genetic basis for preventing, treating and curing disease, and to enable research and education for the global biomedical community.

A part of the proposed tax bill in the US could make tuition waivers taxable, Vox reports.

The New York Times reports that only a subset of STEM worker are in demand.

US News & World Report says students pursuing STEM degrees should consider what they are getting into.

New study finds bias against female lecturers among student course evaluations, the Economist reports.