CDMA Project Lead (Ophthalmic/Vision Science and/or Contact Lens Exp)

Job description

Job Description

•Lead the Clinical Sub Team (CST).

•Key person responsible for the global clinical trial strategy for the products/brand.

•Plan, conduct, and report all clinical trials of an Alcon Project.

•Contributes to the project development plan, including high-level clinical trial design.

•Works with Project Heads (PH) and project core team to create and understand the clinical aspects of the development plan and clinical trial requirements.

•Provides input to the development plan and study concept sheets.

•Designs clinical studies (exploratory, feasibility and confirmatory trials) aligned with the overall project plan.

•Accountable for ensuring high quality, scientifically-sound clinical protocols and related documents that produce clear, decisive results.

•Leads the Clinical Sub Team, in particular, take on responsibility for planning clinical trials, writing study protocols based on concept sheets, investigator brochures and writes study supporting documents.

•Contributes to site selection and CRO selection process.

•Conducts clinical studies, and along with Clinical Manager & ensures study conduct is within timelines and budget.

•Ensures the accuracy of trial information in Clinical Trial Management System (CTMS).

•Contributes to ongoing scientific review of data (data cleaning, safety reporting and related activities.

•Ensures accuracy and timely completion of clinical study reports. Writes clinical content of submission dossiers to regulatory authorities, including, e.g., Q-sub, IDE, CE-Technical Files, and PMAs.

•Serves as Core Project Team Member and is the primary contact for the Project Head (PH)

•Accountable for medical/scientific review of clinical trial data, final analysis and interpretation within clinical trial reports, publications and internal/external oral and written presentations.

•Stay abreast of relevant literature and clinical practice norms for the project/program area(s).

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information

alrpo
Posting Title

CDMA Project Lead (Ophthalmic/Vision Science and/or Contact Lens Exp)

Desired profile

Minimum requirements

• Bachelor’s degree with 5 years of relevant experience OR HS Diploma w/13 years of relevant experience, Associate’s degree w/ 9yrs years of relevant experience Master’s degree w/2yrs years of relevant experience and PhD w/0 years of relevant experience.

•Proficiency in the English required.

•Minimum 5 years technical and operational experience in planning, executing, reporting and publishing clinical studies.

•Well respected in eye care / research community.

•Demonstrated ability to establish strong scientific partnership with key external collaborators.

•Proficient in MS Word, Excel, and PowerPoint.

•Thorough knowledge of Good Clinical Practice, clinical trial design and clinical ophthalmic endpoints/assessments.

•Good understanding of statistics, regulatory processes, and global clinical development process.

•Excellent written and verbal communication skills with successful presentation capabilities.

•Result oriented; quality work provided even when operating under tight timelines.

•Strong track record for being a team player and open for innovation.

•Previous experience in interactions with Health Authorities is preferable.

•Ability to manage multiple projects simultaneously.

Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information

alrpo
Job Type

Full Time
Country

USA
Work Location

Duluth, GA
Functional Area

Research & Development
Division

ALCON
Business Unit

RESEARCH & DEVELOPMENT AL
Employment Type

Regular
Company/Legal Entity

Alcon Research, Ltd.
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.