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Sr. Manager, Clinical Research

3 months ago

Carlsbad, United States Atec Spine Full time


ATEC Spine has an exciting opportunity for a Senior Manager of Clinical Research & Strategy as a member of the Scientific Affairs team located in Carlsbad, California.

ATEC's Scientific Affairs team is responsible for regulatory, testing, and research activities supporting the company's initiatives.

The Clinical Research function, as a sub-function of Scientific Affairs, includes planning, coordinating, and overseeing the successful execution of preclinical and clinical research studies and large-scale data collection efforts in partnership with our surgical practice partners.

Specifically, the Senior Manager of Clinical Research & Strategy position is responsible for defining the strategic direction, resourcing, and managing the execution of the company's clinical evidence strategy, including site-initiated and sponsored protocol-driven research studies and registry data collection and utility.


SUMMARY


From evidence generation to evidence dissemination, the Senior Manager of Clinical Research & Strategy is a liaison between ATEC and our site-based research partners, and as a customer-facing advocate for ATEC's mission, is empowered to take initiative and implement process-improving solutions that enable sites to be successful research partners and that support the company's underlying research objectives.

Internally, the role collaborates closely with other members of the Scientific Affairs teams as well as product marketing, development, and field representatives.

Essential Duties and Responsibilities

  • Along with senior management and in collaboration with relevant stakeholders, leads the development of ATEC strategy to demonstrate the value of our product and procedural solutions through the design, execution, and reporting of clinical and scientific studies
  • Identifies and builds relationships with key opinion leaders (KOLs) to generate clinician collaboration and relevant research projects, building and growing customer and investigator relationships that drive credibility in our products and organization
  • Liaises with the leadership of medical societies, research institutions, and other potential collaborators to facilitate academic partnerships, building and growing a reputation for ATEC as a research-focused organization
  • Oversees the appropriate review, negotiation, and execution of research agreements with sites and third-party partners
  • Bears ultimate responsibility for execution of research projects from start to finish, overseeing the development of study documents, including: protocols, case report forms (CRFs), participant consent forms and other regulatory documents such as for institutional review boards (IRBs); data collection and management, compliant to the protocol and all regulations; data analysis; and report generation, both internal and external (conference presentations, peer-reviewed journal publications)
  • Contributes to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral; assists investigators or customers on the preparation and delivery of research results; manages a publication and podium strategy that effectively increases ATEC's scientific presence and reputation in the spine academic community
  • Maintains a high level of engagement with clinicians and academicians and their scientific findings through attendance at scientific conferences, regularly assessing published literature for trends or novel concepts (with consideration for ATEC solutions and competition), and direct interactions with research partners, peers, and industry colleagues
  • Collaborates closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the clinical activities within the team
  • Collaborates with research and development engineers to provide clinical insight to projects under development
  • Collaborates with marketing teams to provide clinical support for product strategies, collateral creation, and sales needs
  • Manages the execution of projects to budget and time expectations
  • Performs other duties as required
Supervisory Responsibilities

  • Hires and manages clinical research associates, analysts, and/or other scientific personnel
  • Fosters continued development of team members, including technical and clinical expertise
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