Overview

The Clinical Data Manager I performs clinical database setup, maintenance, and data quality control functions through database lock in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and Pharmapace and/or WuXi Clinical and/or Sponsor SOPs. This can be either an in-office or work from home position with less than 20% travel.

Responsibilities

Essential Job Functions:

• Provides operational support for Data Operations
• Serves as data lead interacting directly with sponsor on routine and less complex paper-based or EDC projects under moderate supervision
• May serve as data lead on more complex projects, requiring regular interaction with sponsor and the coordination of one or more vendors, under close supervision
• Performs and is accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database
• Manages processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation
• Functions as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial
• Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testing
• Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support
• May lead internal/sponsor meetings and provide formal training as required
• Performs data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with WuXi Clinical Standard Operating Procedures
• Ensures approved study documentation is maintained and properly stored in the trial master files
• Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients
• Notifies project manager and supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelines
• Assists with training and mentoring of study team members on the DM project specific tasks
• No unlocks of databases due to data errors
• Query and data entry rates considered acceptable per terms of contract
• Accuracy of data updates
• Quality of documentation and accountability of work
• Adherence to timelines and budgets • Organization and coordination on multiple projects
• Train and mentor junior level staff in general team leadership skills, company processes, and project specific tasks
• Good understanding of departmental and company procedures which relate to tasks that are performed routinely
• Position requires employee be aware of budget constraints for time for data entry, query rates, and time to perform other data functions
• Expected to manage to those constraints and to alert project manager and manager if they cannot be effectively managed
• Mismanagement of these aspects and high data error rates could result in missed deadlines potentially affecting project profitability, opportunities for repeat business, contract bonuses or penalties
• May provide technical leadership and coordination of data-related project activities to other team members
• Interacts closely with project manager and supervisor to provide project/budget updates.
• Receives formal administrative supervision from DM Manager or above
• Receives moderate supervision from project managers and supervisor
• In lead assignments, responsibilities may include: coordination of other team members; decision[1]making with data management tasks and processes that are project-specific; providing technical and project guidance and training to other team members; monitoring project status and reporting project metrics; maintaining project timelines ensuring tasks and deliverables are on-time; and, may serve as main point of contact with sponsor and vendors for data-related activities on assigned projects
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
• Normally receives minimal instructions on routine work and detailed instructions on new assignments
• Works under close supervision from supervisor or senior personnel
• Ability to work in a team environment and independently as required
• 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:

• Associates degree with 3 years DM lead experience; OR the equivalent industry work experience (3-5 years)
• BS or MS in Life Sciences or technical degree with 2 years DM experience is preferred
• Must have some experience with DM start up, maintenance and closeout activities in both paper and EDC studies
• Ability to demonstrate knowledge of Good Clinical Practices (GCP), and International Conference on Harmonisation (ICH)

Knowledge / Skills / Abilities:

• Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each
• Ability to effectively communicate issues and potential resolutions to sites, other team members, project manager, and supervisor
• Must show excellent interpersonal communication skills
• Must exhibit positive, professional demeanor in all communications and interactions and must be able to introduce differing communication strategies to solve issues with various team members
• Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
• Must be able to communicate to coworkers and management in a positive, constructive manner and must be comfortable delivering both positive statements and constructive criticism to team members
• Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
• Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work
• Is expected to apply decisions from previous discussions to new situations and seek confirmation only
• Must show ability to review data management documents and files in advance of Quality Assurance review with high level of accuracy
• Makes decisions on the quality of the documents and take appropriate action
• Must make effective decisions on managing tasks within time constraints so that deadlines are not missed
• Expected to require moderate supervision on issues that can have substantial impact on clinical and data quality issues, dependent upon complexity of project and individual experience
• Familiarity with SAS including basic programming skills a plus
• Other programming skills also preferred
• Intermediate skills with Microsoft Office Suite applications; must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation
• Must have ability to initiate steps according to established processes with minimal intervention and new processes with moderate to minimal guidance
• Must have ability to interact with internal and external customers professionally, using clear diction
• Must be able to solve problems independently when required and must be able to anticipate risks to the project within the scope of the position and to propose solutions to supervisor
• Must have positive, professional demeanor with all interactions on the phone or in the office
• Ability to organize workload and handle multiple priorities
• Ability to work in team environment and effectively manage multiple priorities within established time constraints
• Expected to have knowledge of Good Clinical Practices and Good Clinical Data Management Practices
• Ability to occasionally work in remote environment independently, but remain engaged with project team, sponsor, clinical sites, vendors, project manager and supervisor
• Ability to mentor staff
• Travel is required 5% , Domestic/International, Daily / Overnight
• Must have a valid driver's license and the ability 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
• Must be able to perform some activities with repetitive motion, such as keyboarding

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.