Clinical Scientist/Senior (Contract)

reputed company, Inc., wholly owned subsidiary of reputed company, is looking to bring on board a Clinical Scientist/Senior (Contract). This role will support the assigned Clinical Trial reputed company with the design and execution of key elements of the Clinical Development Plan (clinical study or studies) with minimal to moderate level of supervision. This includes activities relating to study design, data reputed company and validation and data analysis and interpretation. This individual will be responsible for implementation, planning, and execution of assigned clinical trial activities for one or more trials, co-Leads study team meetings in partnership with clinical operations and collaborates with cross functional study team members. This position may support clinical development planning (collaboration with Clinical Development reputed company/Clinical Trial Physician for provision and analysis of data to support future planning). Contract duration: 6-12 months Note to Recruiters and Agencies reputed company recruiter and agency inquiries must go through Adverum’s internal reputed company. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s reputed company must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may reputed company your ability to work with Adverum in the future.

What You'll Do

• Support the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.)
• Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites.
• Support cross-functional teams with study protocol and reputed company questions and serves as reputed company of contact for managing/answering questions relating to trial procedures.
• Engages clinical trial vendors to support study start-up activities in line with the clinical trial design
• Provides medical monitoring support or reputed company of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the reputed company or absence of trends and follow up as appropriate
• Collaborate on, or reputed company where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses.
• Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning
• Maintaining awareness of reputed company developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

About You

• MD, PhD, OD, PharmD with ophthalmology experience, preferably including retina experience required. Gene Therapy experience also preferred.
• 5-7 years of experience in a clinical research-reputed company role. 3-5 years' experience in a Clinical science/development role preferred.
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, understanding of functional and cross-functional relationships
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of gene and ocular therapies preferred
• Knowledge of the establishment and operation of data monitoring committees, reputed company review teams, and independent response adjudication committees
• Previous experience working with CROs and other vendors/suppliers preferred
• Previous experience with Phase I-III US and Global/Ex-US clinical trials preferred
• Excellent verbal, written, communication and interpersonal skills
• Proficient in Medical Terminology and medical writing skills
• Proficient critical thinking, problem-solving, decision-making skills
• Adaptable / Flexible - willing and reputed company to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
• Proficient in reputed company Word, reputed company, PowerPoint, and general computer use. Experience using Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools would be a plus.

$70 - $80 an hour The hourly reputed company for this position is between $70.00/hr USD to $ 80.00/hr USD, depending on experience. Apply To This Job