Senior Project Lead - CDMA (Surgical, IOL Diagnostics Experience)

The purpose of this position is to lead the Clinical Sub Team (CST). This will be a key person responsible for the global clinical trial strategy for the products and brand. This position will plan, conduct and report on 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, takes 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 along with Clinical Manager and 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.

• Stays abreast of relevant literature and clinical practice norms for the project/program area(s).
Posting Title
Senior Project Lead - CDMA (Surgical, IOL Diagnostics Experience)

Minimum requirements
• Bachelors Degree plus 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies (or equivalent combination of education and directly related work experience).

• Ability to write, read and speak fluently in English.

•. Experience in managing global multi-center clinical trials across multiple geographic regions.

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

• 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.

• Results oriented with a showing of quality work 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.

Job Type
Full Time

Country
USA

Work Location
Fort Worth, TX

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.


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