Associate Director/Director, Data Management
[ August 18, 2020 ]
The Associate Director/Director, Data Management will provide support for the Company’s products and product candidates in all phases of clinical development (Phases 1-3). The Associate Director/Director will be a key member of a highly collaborative Clinical Development team. This is a hands-on role that may have direct reports in the future.
The Associate Director/Director will have proven leadership ability in a fast paced, multi-location environment and interact with all levels of internal staff as well as external stakeholders, including, but not limited to CROs.
Reporting to the Vice President, Clinical Operations, this position will be located in the Vancouver area, BC, Canada or the Boston area, MA, USA; we may consider other locations for an exceptional candidate.
- In collaboration with Clinical Sciences, Biostatistics, Clinical Operations and other key Development functions, responsible for the design of clinical databases and case report forms
- Oversee data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
- Oversee and contribute to CRF Development, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
- Ensure the delivery of high quality clinical databases by developing procedures for ongoing and final data review
- Optimize data management and collection activities by reviewing protocols for cross-trial consistency and identifying standard case report form modules
- Analyze and evaluate clinical data using SAS, or other computer programming tools to create SDTM datasets, and identify data issues for resolution
- Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations
- Develop and maintain relevant Standard Operating Procedures and other policies, procedures and systems relevant to the department, as needed
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any
- Bachelor’s degree in a scientific, medical, computer science or related field; MS preferred
- A minimum of 8 years of experience in a pharma or biotech environment
- Strong experience in data management-related activities, with thorough understanding of clinical trials process and regulatory requirements, including CDISC requirement
- Strong experience in design and validating EDC databases and performing data review; familiar with safety laboratory data management and dictionary coding for adverse events and medications
- Experience in CNS, pediatric rare disease area and e-diary database design and implementation are preferred
- Successful regulatory submission experience required with new data standards
- Experience in CRO management
- Strong programming skills, in SAS (preferred) or other programming languages. Ability to be hands-on with database programming and cleaning, generate patient level listings as needed
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company
- Proven ability to collaborate in high performing teams; excellent conflict resolution skills
- Be science and data driven while at the same time, be creative and flexible in strategic thinking and problem solving
- Ability to travel up to 10%, both domestically and internationally
To apply for this position, please e-mail your resume and cover letter to email@example.com and include “Associate Director or Director, Data Management” in the subject line. Please save attachments as one file and label it: “Your Full Name – Associate Director or Director, Data Management”. We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.