Lead Clinical Data Manager - Highline

Summary:
The Lead Clinical Data Manager will contribute and lead data management activities in support of client studies across all stages of clinical drug development. They will be responsible for working with cross functional teams leading the data management initiatives.

The ideal candidate has experience working in a global CRO setting with an excellent understanding of data management best practices, good clinical practice, and applicable regulatory requirements. This candidate will have direct experience developing a data management department. Experience with all phases of clinical trials, with strong oncology and phase 1 experience, is critical.

Job Responsibilities:

• Contribute to data management activities in support of clinical studies, including:
  • eCRF development by leading cross-functional reviews of eCRF content
  • Database build activities, including review of edit check specifications and performance
    of user acceptance testing
  • Monitoring data collection, coding, and cleaning by vendors through tracking of study
    metrics and targeted data reviews
  • Oversight of database lock activities and ultimate archiving of study data
• Collaborate with internal and external partners, including Biostatistics, Statistical Programming,
  Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs,
  central and local laboratories, and other vendors
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and
  conduct data reviews
• Review CRO data management plans, CRF completion guidelines, edit check specifications,
  external data transfer specifications and other study documentation
• Represent data management and effectively communicate requirements, strategy, timelines
  and deliverables at internal cross-functional team meetings and meetings with external vendors
• Participate in the drafting and/or review of timelines consistent with company goals and ensure
  all deliverables and milestones are met
• Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
• Support GCP inspection readiness
• Demonstrate clear alignment with company Core Values including, Commitment to People,
  Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
• Performs other duties as assigned
• May involve travel

Demonstration of Highline Values:

Consistently strives to demonstrate the following Highline Sciences values:

• Recognizes that the team is always stronger than the individual
• Seeks to inspire others by demonstrating consistently strong performance
• Treats people with respect regardless of role or point of view
• Listens well and seek to understand before reacting
• Provides candid, helpful and timely feedback to colleagues
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty
• Keeps the bigger picture in mind when making decisions
• Never stops learning
• Questions assumptions and offers suggestions for improvement
• Focuses on results rather than process and seeks to minimize complexity when process is required
• Identifies and addresses root causes, not symptoms
• Demonstrates poise in stressful situations
• Strives to always do the right thing
• Questions actions that are incongruent with Highline Sciences values

Minimum Qualifications:

• BS/BA in scientific discipline, MS or equivalent preferred, with at least 7 years related experience in
  a CRO/pharmaceutical/biologics/biotechnology company
• Study/Vendor oversight experience
• Expert knowledge of Data Management processes, efficient design/build of an EDC data
  management system and other Clinical Trial/Data Management Systems
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC
  SDTM and CDASH
• Experience working with EDC data management systems
• Understanding of ICH GCP as well as general knowledge of industry practices and standards
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems
  including 21 CFR Part 11
• Highly motivated and flexible, with excellent organizational and time management skills
• Ability to work independently and as part of a multi-disciplinary team
• Proficient in Microsoft Word and Excel

Preferred Qualifications:

• Experience with global studies, utilizing an outsourced CRO model
• Experience working with Medidata Rave EDC
• Experience using standardized medical terminology, including MedDRA and WHODrug

Personal Skills:

• Excellent interpersonal and communications skills (verbal and written), as well as problem solving
  and organization skills
• Proven ability to work independently
• Self-motivated, pro-active, and resourceful
• Strong ability to manage managers and/or individual contributors
• Outstanding organizational skills
• Excellent analytical and problem-solving skills
• Excellent communication skills with a diplomatic approach including the ability to work with various personalities and perspectives
• Excellent ability to lead cross-functional initiatives related to Data Management
• Demonstrated proactive thought process to minimize and mitigate risk independently
• Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving and process improvement development
• Excellent presentation skills: internal, external

About Highline

• We actively strive to differentiate ourselves to both employees and clients with our unique culture that has been created very intentionally with much care and effort.
• Our core belief is that it’s all about the team. More specifically, bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring and successful organization. We also happen to have a lot of fun!
• We believe in questioning the norm and looking for alternatives. We seek out team members who are driven by curiosity and understand the power of the collective. We encourage continual learning and constructive feedback. We strive to build and maintain trust, both internally and externally.
• We provide a supportive, open culture and empower every team member to speak up, voice questions, offer solutions, and actively contribute to the overall success of the company and our clients. We trust team members to take responsibility for demonstrating the highest standards in their personal actions and relationships and holding one another accountable