Senior Customer Implementation Manager

Remarque Systems Inc. North Carolina


Description

Bring your Passion to Remarque! Remarque Systems is a software company that is passionate about improving drug development using cutting edge software.  Founded in 2015 Remarque Systems is focused on Clinical Trial Software to support Risk Based Monitoring and Quality by Design.

We’re looking for an exceptional Senior Customer Implementation Manager to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

The Senior Customer Implementation Manager is responsible for becoming an expert in the Remarque System Platform and demonstrating the ability to transfer that knowledge effectively and efficiently to our partners and customers.  Act as the primary contact for customers during RSP implementations and working with the customer engagement team to ensure all relevant and useful requirements are obtained and appropriately configured to meet customer expectations.  Provide support and training during the configuration and maintenance of Remarque System Platform.

What you'll be doing:

  • Responsible for all assigned customer engagement (system setup, risk evaluation, study setup, project management, training)

  • Act as primary contact for Remarque with customer

  • Managing the customer relationship from the hand-off from Sales through the transition to maintenance phase

  • Assists in set-up of RSP for assigned customers and studies

  • Leading and conducting working sessions with customer team (monitoring, study teams, statistics, data management, clinical operations, etc) and Customer Data Integration Engineer to establish appropriate parameters for the RSP.

  • Responsible for researching and communicating study design and contents of client protocols

  • Identifies study risks and helps evaluate risk profiles with customer

  • Responsible for developing/streamlining the process upon which customers/trials are on-boarded

  • May provides RSP training via instructor led training

  • May investigate, document, and bring to resolution user issues with the RSP

  • Interface with development on behalf of the customer during product delivery lifecycle to ensure customer expectations are met in final product

  • Provides UI Design and expertise for the user interface, particularly from a user perspective

  • Works with Support, Testing and other technical and customer leads to ensure a smooth co-operation between responsibilities and handling of user requests

  • Contribute to the utilization of standard tools, methodologies and templates to aid in successful system implementations

  • Being viewed as a Risk Management expert able to provide configuration input to meet customer needs

  • Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)

  • Helping others to accomplish results

  • Performing other duties as assigned and deemed necessary.

You'll need this to be considered:

  • Bachelors in biological sciences or closely related field

  • 10+ years of experience in clinical trial execution

  • Minimum of 15+ years of experience in the health care field

  • Demonstrated experience with regulatory agencies (e.g. FDA, MHRA, EMEA, EU member states)

  • Clinical trial monitoring experience within a CRO, device or pharmaceutical research organization in a system implementation related position preferred

  • Knowledge of ICH/GCP and local regulatory authority drug research and development regulations required

  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures

  • Demonstrated technical aptitude and the ability to learn new technology quickly, proficiency with general computer hardware and software

  • Ability to create new processes and able to manage and implement corporate change

  • Comfort with training users new to Remarque products on basic and advanced features.

  • A disciplined self-starter an excellent team player, collaborative and able to encourage effectiveness and efficiency

  • Ability to multitask and work effectively in a fast-paced environment with changing priorities

  • Strong verbal and written communication skills across all levels of the organization

  • Excellent organizational and time-management skills, able to prioritize work to meet deadlines

  • Accountable, dependable and strong commitment

  • Is customer service focused in approach to work both internally and externally 

  • High standard for quality, execution and customer relationship management

  • Excellent independent judgement and problem-solving skills

  • Results and goal oriented

  • Proficiency in Microsoft Excel

  • Up to 10% travel is involved