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Senior Clinical Data Manager

Company: WuXi AppTec
Location: Austin
Posted on: May 3, 2021

Job Description:

Overview

WuXi Clinical, a wholly owned subsidiary of WuXi AppTec, is a global Contract Research Organization (CRO) providing a comprehensive range of services in clinical development. We provide Phase I to Phase IV clinical development services & BE (Bioequivalence), for products including pharmaceuticals, biologics, and medical devices. With expertise spanning all major therapeutic areas, we deliver the unique blend of an experienced team, combined with the creativity, responsiveness, and customer centric-focus of a highly nimble organization. This forward-thinking approach has allowed us to work on a variety of projects ranging from first-in-human products to marketed drugs and devices.

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. Since our founding in 2013, Pharmapace has successfully assisted numerous biopharmaceutical companies in their drug development programs. Many of the drugs that our team has worked on have received approval by the US Food and Drug Administration. We take great pride in what we do to help our valued customers to advance human health.

In early 2019, Pharmapace was acquired by WuXi AppTec, a leading global contract service company that serves over 3,700 biopharma companies worldwide. Pharmapace will continue to operate as a California corporation as a subsidiary of WuXi AppTec and will remain committed to delivering exceptional services and value to our customers. Pharmapace will be an integral part of WuXi Clinical which has offices in Austin, Texas, Taiwan, and China. This combination allows us to leverage on WuXi Clinical's vast resources and offer our customers a truly global solution to all aspects of clinical/drug development and regulatory submission.

Founded in 2000, the WuXi AppTec is the leading global pharmaceutical, medical device open-access capability and technology platform company with more than 25,000 employees across 25 locations globally. The WuXi platform is enabling more than 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi AppTec's dream that "every drug can be made and every disease can be treated."

Responsibilities

Job Summary: The Senior Clinical Data Manager provides high quality data management services through strong leadership and task execution for all data management services from project start up to closeout. The Sr. CDM ensures quality deliverables are on time, within budget, and in accordance with Clinical Data Interchange Standards Consortium (CDISC) standards, Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and WuXi Clinical and/or Sponsor Standard Operating Procedures (SOP) and Work Instructions (WI). This can be either an in-office or remote position.

Essential Job Functions:

  • Serves as primary point of contact for the project team, sponsor, and vendors on complex/ high volume EDC and/or paper hybrid projects within minimal to no supervision
  • Demonstrates strong attention to detail, project management skills, organization skills, and accountability for all data management activities
  • Manages processes to ensure data integrity in accordance with WXC SOP/WI and/or approved project documentation
  • Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, defining validation specifications, test script development, and user acceptance 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 such meetings and provide formal training as required
  • Assists with training employees on departmental procedures and processes and technical tasks
  • Performs data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with WXC SOP/WI
  • Ensures approved study documentation is maintained and properly stored in the trial master files
  • Performs Business Development functions including, but not limited to, slideshow preparation and data management presentations for potential sponsors
  • Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients
  • Contributes to the overall operations and to the achievement of departmental goals
  • Successful completion of projects with a focus on customer satisfaction and an emphasis on generating repeat business

Qualifications

Experience / Education:

  • BS or MS in life sciences, technical, or related discipline with minimum 4 years data management lead experience in CRO or Pharma required. Global project lead experience is preferred.
  • Candidates with less lead experience will be considered for Clinical Data Manager II level
  • Experience in moderate to complete clinical trials preferred

Knowledge / Skills / Abilities:

  • Must have extensive experience in managing Clinical Data Management Systems (CDMS) from project start up through archival
  • Ability to work in fast-paced environment
  • Good working knowledge of CDISC, GCDMP, GCP, and ICH guidelines
  • Good understanding of medical terminology
  • Ability to utilize experience and knowledge to make logical and appropriate decisions on a wide range of data management projects and tasks with little or no guidance or supervision

Ability to effectively deal with complex client interactions and good problem resolution skills

  • Excellent verbal communication, interpersonal, and mentoring skills
  • Must exhibit concise technical writing skills in English with minimal grammatical or logical errors.
  • Ability to oversee financial budgets for proposed projects
  • Ability to identify and report potential out of scope activity on assigned project to DM management and assist with contract modifications
  • Ability to maintain a high degree of confidentiality of proprietary data
  • Familiarity with SAS including basic programming skills a plus
  • Proficient with Microsoft Office Suite applications
  • Must have strong attention to detail and demonstrate understanding of the critical nature of WuXi Clinical documentation

Physical Requirements:

  • Must be able to travel (5%, Domestic/International, Daily/Overnight; if driving, must have valid driver's license and be able to rent a car)
  • Must be able to work in an office environment, which has minimal noise conditions or have a home-based office area to work for remote positions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding
  • If working remote: must be able to travel for long distances in various methods of transportation

(e.g. car, airplane, shuttle bus, train, etc.) on an infrequent basis

  • Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop when traveling

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.

Keywords: WuXi AppTec, Austin , Senior Clinical Data Manager, Other , Austin, Texas

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