Senior Clinical Data Coder

Job Overview
Manage single and multiservice projects ensuring quality deliverables on time within budget and to the customers satisfaction; Provide expert skills as part of a Clinical Data Management (CDM) team to provide quality data that meet customer needs; Provide leadership to the team in the area of coding project planning and financial management communication and milestone tracking; Viewed as an expert in coding of clinical data; May perform the role of a Data Operations Coordinator (DOC) Data Team Lead (DTL) and a customer site lead or may be responsible for managing and delivering a program of studies for a customer.

Essential Functions
Serve as an account lead or internal or external point of contact on standalone coding studies or accounts
Manage the customer relationship for the project team including active participation in coding related customer negotiation on timeline budgetary and other issues
Provide leadership and senior support to lead coders on one or more large global studies
Manage the relationship with a customer on a DM site level
Serve independently as a Lead Data Coder and/or Coding reviewer for one or more projects
May serve as a DOC or DTL for one or more projects
Perform comprehensive quality control procedures
Perform Serious Adverse Event (SAE) reconciliation activities
Collaborate with customers and develop solutions and action plans for issues escalations and road blocks
Proactively identify solve quality issues and deliver projects as per agreed timeline
Identify and provide due diligence for out of scope activity
Manage resource capacity for the project team
Mentor other team members in training and developing coding expertise
Independently bring project solutions to the Coding and CDM team
Identify and implement processes and quality improvement initiatives in the DM and coding function
Developing and implementing best practices in the team
Manage the development and implementation of new technologies
Demonstrate scientific and research temperament by presenting at or participating in local and international forums
Responsible for identifying and implementing process improvements using established methods (principles of lean and six sigma) in collaboration with experts
Provide review and expert opinion in developing revising and maintaining standard core operating procedures and work instructions
Perform other duties as directed by the DOC DTL or Manager or meet objectives as assigned
Develop and maintain good communications and working relationships with the CDM team and client stakeholders

Qualifications
High School Diploma or equivalent Pharmacy dental medical nursing life sciences or related field qualification or educational equivalent Pref
7 years relevant experience in clinical trials within a similar function including proven competence in managing the delivery of coding or/and other data management processes for multiple global projects also including experience in handling complex customer negotiations and bid defense meeting. Pref
Excellent knowledge of Medical Dictionaries used for coding (e.g. MedDRA WHODD ICD9 etc..
Excellent knowledge of Medical Terminology Pharmacology Anatomy and Physiology required for many tasks.
Advanced knowledge of data management processes and systems and advanced ability to apply this knowledge in practice.
Excellent understanding of clinical drug development process (detail oriented).
Outstanding communication and organizational skills.
Proven leadership skills.
Good project management skills related to all phases of clinical studies.
Excellent knowledge of operating procedures and work instructions and the ability to apply them in practice.
Excellent English written and oral communication skills.
Ability to work on computer systems with ease and good working knowledge of computer programs.
Ability to exercise excellent attention to detail and act independently with the initiative required to resolve problems.
Ability to establish and maintain effective working relationships with coworkers and managers.
Comprehensive understanding of financial management concepts and able to interpret the financial information.
Able to present information effectively to individuals and groups.
Able to make independent decisions within scope of authority and considers the impact of decisions on other groups and people.
Able to motivate and lead teams to reach defined objectives.
Effective team management skills including conflict resolution delegation and change management.
Excellent interpersonal skills.
Able to establish trust and collaborative relationships with customers.

This role is not eligible for UK visa sponsorship

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