Senior Clinical Data Lead

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with. 

Overview

Provides support to the Data Management Project Manager and junior Data Management team members.  Drives tasks related to database build and testing.  Leads the development of data management-related study documentation and study meeting agendas and minutes.  Supports all data cleaning activities (query review and resolution, data listing review, etc.).  Liaises directly with internal and sponsor study teams.  May also be responsible for the development and review of company standard operating procedures and development of study department performance metrics.

Responsibilities

• Responsible for timely, complete, and accurate project deliverables within the data management scope of services 
• Develop CRF specifications while collaborating/supporting Clinical Database Programmer
• Develop eCRF database and related edit checks from the study protocol 
• Develop eCRF Completion Guidelines 
• Create and maintain data management study documentation (i.e., Data Management Plan, eCRF completing guidelines, edit check specifications, data management report specifications, project specific training, Electronic Data Capture testing) 
• Facilitate and participate in user acceptance testing activities with study team and coordination of findings through resolution with appropriate team members
• Develop database validation test scripts
• Oversee database go-live, change control, and database lock activities
• Oversee and support issuance of queries and review query responses by junior team member 
• Identify database modifications and ensure they are communicated to study team members.
• Participate in MedDRA and/or WHODrug coding
• Ensure any Postproduction/Mid-study Updates are approved in writing by client before any database changes are made.
• Provide sponsors, and study team members updates on data cleaning and review activities. 
• Participates in and leads client team meetings with respect to data management activities as applicable
• Provides training to study team on use of electronic study database via web conference or in-person 
• Supports the Data Management Project Manager with the monthly revenue review update for assigned studies

Requirements

Education:

Required: a BA/BS degree in the biological sciences or related disciplines in the natural science/health care field (or equivalent education, training and experience.)

Experience:

This position requires 8+ years of hands-on clinical data management experience, preferably in a clinical research setting.

Skills:

• Knowledge of medical terminology preferred.   
• This position requires at least five years in a team leadership and mentoring in clinical data management. 
• Exceptional data management experience or equivalent combination of education and experience.   
• Experience with data management practices and relational database management software systems.   
• Knowledge of Good Clinical Practices (GCP) and Good Clinical Data Management Practices (GCDMP) 
• Experience with one or more commercial EDC platforms (Medrio, MedNet, Merge, RAVE) 
• Competent computer skills including MS Office Suite 
• Excellent customer service skills
• Demonstrated excellent communication skills (written and verbal) 
• Attention to detail 
• Manner of interactions demonstrates an understanding of the value of developing positive relationships 
• Ability to resolve routine problems and elevate issues appropriately 
• Ability to work in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities 
• Possesses active listening skills and proactively seeks clarification and additional information as needed.
• Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute. 
• Ability to learn new things and teach others.

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.