Amick Brown is seeking an experienced Project (Clinical) Manager
for our direct client.
: Sunnyvale, CA
: 9 months
Roles & Responsibilities
- This position reports to Manager or Senior Manager, Clinical Affairs and requires a strong candidate with experience supporting evidence generation strategy and execution of clinical studies and registries.
- A candidate must have some previous experience around understanding clinical literature, clinical research, and/or clinical affairs The Clinical Project Manager will develop strategies for clinical and outcomes research studies.
- As Clinical Project Manager, this role will be responsible for working with keys stakeholders to design and develop clinical protocols and execute clinical studies (pre and post-market) with some supervision.
- The candidate will be required to work closely with data management and biostatistics to review and interpret the results of clinical studies and to develop a clinical study report or support the development of clinical publications.
- The ideal candidate will have experience previously managing clinical studies in the United States and utilizing resources to research and scope a research topic and provide recommendations on clinical trial strategy.
- The candidate is also expected to have experience in reviewing, interpreting, and summarizing clinical literature.
- Responsible for leading pre and post-market clinical research activities
- Collaborate with internal stakeholders and KOLs (key opinion leaders) to develop and review study concepts, protocol, and study outlines and subsequently driving identified initiatives
- Conduct literature searches to stay abreast of scientific knowledge and to determine the evidence gaps.
- Responsible for the planning and execution of the clinical studies including investigator selection, analysis of potential patient recruitment, supporting the creation of study-related documents (including protocols, case report forms, Informed consents, Clinical trial agreements), organizing IRB/EC submissions with following thoroughly to ensure a successful outcome
- Responsible for independently conducting clinical studies on schedule and within budget while ensuring high quality and compliance
- Liaise with external vendors and sites to negotiate contracts and budgets
- Track study progress and provide a status report every week
- Participate in data analysis, interpretation, and synthesis, instruction to develop Clinical study report and /or support the development of scientific publications including peer-reviewed manuscripts in partnership with external key opinion leaders
- Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines)
- Critically appraise scientific literature and write clinical summaries to assist research efforts and development of clinical strategies and clinical investigational protocols.
- Review and revise Clinical Operations Standard Operating Procedures (SOPs) to assist Clinical Affairs Leadership with continuous process improvement initiatives.
- Collaborate with commercial groups (i.e. marketing) to understand market trends and utilize information to support business goals through Clinical Affairs activities
- B.S. in bioengineering or a relevant scientific field, with an advanced degree, preferred & with 4-6 years or equivalent relative industry experience preferred
- Previous experience in implementing, supporting, and managing pre and post-market device trials
- Knowledge of clinical and outcomes research study design is necessary.
- Experience in conducting literature searches, reviews, and appraisal of scientific data is preferred
- Experience in protocol development and/or writing clinical section for regulatory submission is preferred
- Ability to interact with physicians and other professionals inside and outside the company.
- Possess knowledge of Good Clinical Practice ICH/GCP, 21 CFR Part 11, and international regulations.
- Comfortable in a hospital environment, with experience working with nurses and surgeons
- A basic understanding of statistics, statistical methods, and design of the experiment is a preferred
- Must have a high level of attention to detail and accuracy.
- Must be able to work effectively on cross-functional teams.
- Must be able to travel up to 10-20%
- Must be able to manage or support multiple projects
- Strong communication, presentation, and interpersonal skills with high attention to detail and organization
- Ability to learn quickly and self-educate on different surgical specialties as applicable to clinical projects (Self-starter attitude)
- Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits:
- 401k with company match
- Paid time off
- Sick Leave
- Short-Term Disability
- Life Insurance
- Wellness & Discount Programs