Associate Director, Clinical Data Management (J-Review System Lead)

Genmab A/S Princeton , NJ 08544

Posted 2 months ago

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

The Role

Genmab is looking for a highly motivated and experienced J-Review Clinical Systems Lead, with a minimum 7-10 years of experience from the Pharmaceutical/Biotech industry, to join Clinical Data Management within Clinical Operations. The J-Review Clinical Systems Lead is responsible for implementing, growing and maintaining the J-Review system to support data review and cleaning activities for clinical trials. This is a new position with high influence on the development of effective data review and cleaning tools and strategies.

In the role of J-Review Clinical Systems Lead, the employee will be responsible for supporting Data Management, Medical and other functional areas within R&D with the implementation and operation of J-Review Cloud for clinical data oversight and data cleaning activities and solutions. This encompasses the oversight of the end-to-end implementation of the J-Review application including object specification, management of daily operations, process development, training oversight and end-user adoption. The J-Review Clinical Systems Lead will act as the operational point of contact for the J-Review application and will ensure the development of data review and cleaning tools that optimally support the end-user requirements. The employee will chair a J-Review Core Team and interface with data review subject matter experts, driving the implementation and oversight of the application. The J-Review Clinical Systems Lead will coordinate with Integrated Clinical Systems and the IT organization regarding system hosting and maintenance to support daily operation of the application.

Further, the Associate Director, Data Management will support the development and optimization of processes and tools to enable success of the Clinical Operations department.

Responsibilities

In this position, you will be reporting to the Head of Clinical Data Management. The J-Review Clinical Systems Lead will work closely with key stakeholders to ensure the implementation, growth and maintenance of the J-Review application to support successful clinical trial conduct. The key responsibilities include, but are not limited to:

  • Serving as the subject matter expert in data review and cleaning capabilities and functionalities of the J-Review application.

  • Facilitate business requirements, collect needs, assess and propose solutions, including creation of object specifications.

  • Collaborate with end-users to determine the best solutions to fulfill business needs within the J-Review application.

  • Develop new and innovative J-Review objects that are fit-for-purpose, deliver high business value and maximize data reviewer effectiveness.

  • Work collaboratively with IT to develop and support processes to maintain and administer the J-Review system (user access administration, change control, etc.)

  • Manage the roll-out of the J-Review application to end-users including the planning, object development and verification, SOP/process development, training and end-user support.

  • Chair J-Review Core Team and interface with data review subject matter experts across functions to drive the implementation and oversight of the J-Review application; engage with super-users to maximize adoption, streamline requirements and define business processes.

  • Develop and support business processes that define the use of J-Review application and outputs in data review and cleaning activities across various stakeholders in Clinical Operations, Medical, Pharmacology and other R&D Functions; ensure consistent implementation of application across trials.

  • Develop and maintain SOPs, Work Instructions and other documentation related to J-Review application.

  • Interface with Integrated Clinical Systems regarding application hosting, maintenance and object development.

  • Keep oversight of end-to-end dataflow, feeding into and reporting out of the application, including troubleshooting and issue resolution. Interface with DM CROs and other 3rd party vendors to ensure data flow into ICS per requirements.

Requirements

  • The Associate Director level requires a minimum of 7-10 years' experience with clinical data management in the pharmaceutical/biotech industry, preferably within the oncology therapeutic area. The level of this position will reflect the experience and seniority of the candidate.

  • Extensive experience with clinical trial data and how to present clinical data in a meaningful way for data review and cleaning purposes; capable of presenting solutions to meet complex data review and cleaning needs.

  • Proficient in the use of J-Review; capable of specifying, developing and verifying J-Review objects. Strong understanding of SQL programming. Understanding of R programming an advantage.

  • Prior experience with Electronic Data Capture systems required, preferably Medidata Rave.

  • Experience with clinical data interfaces and data exchanges with CROs and other vendors.

  • Experience working as a liaison between Medical/Clinical and IT. Experience translating medical/clinical user requirements into accurate technical specifications and outputs.

  • Understanding of IT systems lifecycle; understanding of the application validation process

  • Project Management skills; excellent organizational skills

  • Knowledge of clinical trials and the drug development process.

  • Knowledge of medical and statistical terminology, preferably within oncology.

  • Understanding of GCP-ICH, SOPs, regulatory requirements and Good Data Management Practices, including a strong understanding of 21 CFR Part 11 and GxP complaint systems.

  • Good oral and written communication skills

Moreover, the following personal requirements describe you:

You are a dedicated and engaged team player.

You easily build relationships and are a clear and direct communicator.

You have a quality mind-set.

You are adaptable and able to prioritize your work in a fast paced and changing environment; you are agile and resilient.

You drive performance and are a fast learner.

You are a self-starter, quickly able to identify what needs to be done and take action.

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Associate Director Data Management (Remote)

Amicus Therapeutics, Inc.

Posted 2 weeks ago

VIEW JOBS 10/1/2021 12:00:00 AM 2021-12-30T00:00 Associate Director, Data Management SUMMARY OF POSITION Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases. The Associate Director, Data Management collaborates closely with counterparts in Clinical Operations and in Translational Sciences to ensure excellent operational oversight of clinical studies. The Associate Director, Data Management interfaces effectively with the study DM vendor and the Amicus study team to plan, manage and ensure execution of all tasks from protocol design to final CSR, to produce high-quality study data and to achieve corporate goals on time and on budget. ROLES AND RESPONSIBILITIES The Associate Director Data Management is responsible for: * Ownership of clinical study databases. * Accountable for database integrity and accuracy. * Oversee data management activities at vendor from CRF/database development through database lock. * Collaborate with study team during protocol development with the mindset of "start with the end in mind" to ensure the operational team is poised for successful data to enable the program strategy. * Lead all DM activities including data collection forms (CRFs, diaries and CRF completion guidelines), clinical databases, study related data management documents, SOPs, etc. * Work closely with Translational Sciences during study start-up to ensure Central Lab database is designed and programmed appropriately. * Adhere to FDA regulations (21 CFR Part 11, GCP), ICH guidelines and internal SOPs. * Lead oversight of quality data and timeliness of all deliverables from DM vendor * Ensure the completeness, accuracy, and consistency of data so that they meet the standards of quality expected for reporting to regulatory bodies. * Interface with CRAs and other Clinical Operations team members to ensure the quality of data collection. * Lead data transfers agreements with 3rd party labs to ensure the appropriate formatting, conversion, and transfer of external data. * Communicate regularly with other team members to report and resolve issues * Track data management performance. * Coach and mentor all staff under him/her; set objectives, solicit 360° feedback from stakeholders and conduct performance reviews to foster growth of staff. * Ensure all necessary training is provided to his/her staff to support job performance and knowledge; remain cognizant of, and remove, any barriers or obstacles that impede his/her staff from achieving objectives. QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements * BS or BA in relevant field required Professional Work Experience * Minimum of 8 years of clinical data management experience, including database set-up, data validation and consistency checks, initiation and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data, coding, and SAE reconciliation or equivalent * Proficient in the use of clinical data management systems, including paper based and EDC systems, IVRS systems, and online enrollment * Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs * Excellent written and oral communication skills, including experience with production of requirements documents, technical specifications, and other components of a clinical study database development process * Knowledge of clinical data acquisition standards harmonization (CDASH), experience with SAS programming or relational databases a plus * Proficient in the use of data management tools * Self-motivated and able to function with little supervision * Highly detail-oriented * Excellent interpersonal skills * Superior communication skills, both verbal and written; able to synthesize complex data and ideas and summarize for senior management * Good team player * Able to resolve conflicts in a diplomatic manner * Demonstrated leadership skills * Ability to manage up and down * Good negotiation skills * Solid problem-solving and decision-making skills Location * This position will be based at Princeton NJ or Remote or as indicated in the Employment Contract. * Domestic and International travel required up to 10% We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our "Three Pillars of DEI" are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement. Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law. Amicus Therapeutics, Inc. Princeton NJ

Associate Director, Clinical Data Management (J-Review System Lead)

Genmab A/S