Overview

Pharmapace, Inc. ("Pharmapace") is a consulting and contract Clinical Research Organization ("CRO") founded by a group of veteran leaders in the biotech/pharmaceutical industry who are recognized experts in their respective fields. Pharmapace's core mission is to deliver exceptional value to biotech/pharmaceutical companies by providing high-quality consulting and outsourcing services to support our customer's clinical trials, regulatory submissions, medical affairs, safety surveillance, and outcomes research programs to help patients afflicted with a wide range of disease conditions.

The Technical Data Manager performs clinical database setup, maintenance, and data quality control functions through database lock in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and WuXi Clinical, and Sponsor SOPs.

Responsibilities

Essential Job Functions:

• Serves as clinical database designer.
• Responsible for the development of eCRF specifications and/or validation check specifications to meet the needs of the customer and the clinical trial utilizing protocol and specifications provided at the pre-design meeting. Understands WuXi Clinical EDC and Paper processes
• Advises and provides justification for design decisions to Lead Data Manager, Programmer and/or Statistician.
• Responsible for optimal design reducing the number of edit checks required, ensuring good system performance, and the utilization of global/client specific libraries to ensure consistency and efficiency.
• Works closely with Biometrics team to ensure CDISC compliant data is delivered from the clinical database
• Requires a technically logical thinker to resolve questions and issues with the Biometrics team. This role will need to have a good knowledge of forms design, data flow, and the impact of design on the system
• Responsible for reviewing all clinical database software release notes for changes to verify their effects on DM systems
• Determines if clinical database software release notes require a performance qualification UAT and send the recommendations to DM and QA Management.
• Writes the UAT plan, traceability matrix, and scripts for all release notes that require UAT or execute DM software release note UAT scripts if not the author of the scripts to be executed
• Performs system validation User Acceptance Testing (UAT), as applicable, and maintains documentation supporting this practice for all clinical database systems used by WuXi Clinical Data Management.
• May assist QA in writing the validation certificate and/or summary for DM software release notes that have been validated
• May assist QA with the validation of any new DM software that is purchased, which may include assisting in writing the validation plan, URS, risk assessment, traceability matrix, PQ/UAT, validation certificate, and validation summary
• Assists Lead Clinical Data Managers with DM study startup activities, including CRF/eCRF design, CRF annotation, developing database specifications, defining validation specifications, and database and validation specification user acceptance testing. May also assist leads with database modification and database lock activities.
• Serves as data management lead interacting directly with sponsor, sites and vendors on complex paper-based or EDC projects under minimal supervision. Responsible for all tasks associated with Sr. CDM role.
• Assists with training and mentoring of DM personnel on DM project specific tasks, departmental procedures, clinical database systems, and technical tasks.
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
• Other duties as assigned
• May be required to assist in other departments

Qualifications

Experience / Education:
• BS or MS in Life Sciences or technical degree with 4 years DM lead experience is preferred
• Must have extensive experience with DM start up, maintenance and closeout activities in both paper and Electronic Data Capture (EDC) studies
• Experience in moderate to complex projects, paper based, and EDC projects. Global project experience preferred

Knowledge / Skills / Abilities:

• Certified database designer
• Ability to work in a team environment and independently as required•
• Must have experience in managing clinical trial databases in Pharmaceutical or related industry including global projects a plus. Experience with both paper-based and EDC studies preferred.
• Familiarity with SAS including basic programming skills a plus. Other programming skills also preferred. Advanced skills with Microsoft Office Suite applications
• Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation.
• Ability to work effectively in fast-paced changing environment and effectively manage multiple priorities within established time constraints
• Strong organizational, planning and follow-up skills and the ability to hold others accountable
• Must have ability to initiate steps according to established processes without intervention and new processes with minimal guidance.
• Must have ability to interact with internal and external customers as necessary
• Must be able to solve problems independently when required and must be able to anticipate and judge risks to the project and to implement or to propose solutions to supervisor when required.
• Ability to work in team environment and effectively manage multiple priorities within established time constraints.
• Ability to mentor staff.
• Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data Management Practices.
• Approximately 5% travel required; if driving, must have valid driver's license and be able to rent a car.

Physical Requirements:

• Must be able to work in an office environment, which has minimal noise conditions
• Ability to stand or sit for most of the work day or have a home-based office area to work for remote positions
• Must be able to perform some activities with repetitive motion, such as keyboarding

WuXi AppTec requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine by February 9, 2022 or undergo weekly COVID-19 testing as set forth in WuXi AppTec's Mandatory COVID-19 Vaccination Policy, unless they are eligible for an exemption from the vaccination or testing requirements based on a disability or sincerely held religious belief, practice or observance. If you are offered employment with WuXi AppTec, you will be required to provide acceptable proof of your COVID-19 vaccine (if applicable) no later than 8 days before your first day of employment.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.