Medical Scientific Affairs Clinical Liaison CL
Medical Scientific Affairs Clinical Liaison CL
Posted on :
30-04-2025
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1 Vacancy
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Job Description
Description
The Medical & Scientific Affairs Clinical Liaison (CL) involves providing scientific support for the conduct of and publication of scientific studies. The CL will interact with personnel across the organization including R&D and Regulatory Marketing as well as customers when needed. The CL provide on site monitoring of studies as well as assist in the development of writing protocols and maintaining scientific references for publications and white paper development.
Under limited supervision general direction etc. and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position:
- Maintain and help develop scientific reference library/database including using AI scientifictools.
- Support R&D and Investigator Initiated Study (IIS) Programs as site monitor and participate in protocol and scientific studies.
- Manage IIS Review Committee Meeting activities: Track and review all new proposals/protocols received conduct committee meetings collaborate with Medical Team prepost mtgs.
- Work on site in Irvine with R&D on Pilot Studies in readiness for External Studies
- Coordination of Medical Affairs attendees at scientific congresses
- Track study milestones & process payments with Medical Affairs Leadership
- Perform site monitoring visits (selection initiation monitoring and closeout visits) in accordance with contracted scope of work and regulatory requirements.
- Work with sites to adapt drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals recruitment and enrollment case report form (CRF) completion and submission and data query generation and resolution. May support startup phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigators Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Follow and Maintain Scientific Reference Database for Publications and Medical Affairs Support
- Conduct literature searches and review scientific publications to support Medical and Scientific Affairs functions. This can include medical writing.
Qualifications:
- Minimum of a Bachelors Degree in Life Sciences Healthcare Administration or related fields such as Nursing Pharmacy. Masters a plus.
- Minimum of 5 years site monitoring and or Clinical Research Organization and/ or Medical Affairs Study Experience
- Proven technical and scientific writing skills
- Travel up to 25
- This hybrid role is expected to work on site (Irvine) 23 days as needed to do studies at the R&D laboratory
- Highest level of integrity and ethical decision making
- Innate desire to focus on patient safety outcomes
- Exceptional interpersonal skills and willingness to work in a team environment
- Strong organization skills with the ability to prioritize task and meet deadlines
- Proficiency in Microsoft Office Suite (Word Excel PowerPoint Outlook)
- Proficiency with Project Management/Dashboard Platform Software
- Familiarity with project management tools and software
- Ability to coordinate and lead multiple projects simultaneously
- Ability to understand and assess complex clinical matters
- Collaborative work style
- (Include any required computer skills regulatory knowledge certifications licenses languages cognitive and behavioral abilities etc.
Nicetohave:
- Experience in medical devices pharmaceuticals or diagnostics
- Knowledgeable of U.S. Food and Drug Law and regulatory drug safety and/or device vigilance and/or regulatory/clinical research requirements in major geographies.
#LIRB
Employment Type
Full-Time
Key Skills
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