The Associate Manager, Clinical Science / Medical Affairs is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies for a dynamic portfolio of products across TMTT.
As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy, clinical study design, clinical evaluation reports, clinical study protocols, risk management, and /or clinical studies in alignment with the TMTT business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio.
The Associate Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Authors clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market) and other scientific documents (as appropriate).
Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER and other subject matter experts to create documents and that effectively and clearly describe research results, product use and other medical information.
Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing and summarizing data from all applicable sources
Maintain current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
Collaborate with cross functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
Independently review raw and summary data for accuracy.
Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate)
Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up.
Ensure documents comply with regulatory guidelines.
Up to 15% travel to conferences/physician meetings.
Education & Experience:
Bachelor's Degree in a related field with 8 years of previous clinical science experience, a Master's degree with 6 years, or a PhD with 4 years, preferably within the medical device industry
Must be familiar with the coronary interventional and structure heart environments and current treatment options or have other clinical and/or clinical trial experience that fulfills this requirement.
Must have an understanding of Good Clinical Practice requirements and ICH guidelines.
Experienced with literature reviews and various publication databases including PubMed.
Strong analytical, problem-solving, and scientific writing skills
Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
Excellent oral and written communication skills
Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote and Adobe Acrobat
He/she must be assertive, persistent, detail- oriented, and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
Edwards Lifesciences Corp