Manager/Senior Manager, Data Management

We are seeking a Manager/Senior Manager, Data Management to join our team. The Manager/Senior Manager will lead and manage data management activities for assigned products, product candidates and/or clinical trials in all phases of clinical development (Phases 1-3). The Manager/Senior Manager will be a key member of a highly collaborative Clinical Development team. The Manager/Senior Manager will thrive in a fast paced, multi-location environment and interact with internal cross-functional colleagues, as well as external stakeholders, including, but not limited to CROs.

This position reports to the Executive Director, Data Management and will be located in the Vancouver, BC, Canada location. The level of the position will be commensurate with the candidate’s education and industry experience.

RESPONSIBILITIES:

•    In collaboration with Clinical Sciences, Biostatistics, Clinical Operations, and other key Development functions, responsible for the design of clinical trial databases, which includes, but not limited to, CRF Development, Database Validation, and Data Review tools in accordance with ICH/GCP guidelines and current regulatory requirements.
•    Oversee external data management vendors in respect to key performance indicators, metrics, program level deliverables, timelines, and budgets; may participate in vendor selection activities.
•    Optimize data management and collection activities by reviewing protocols for cross-trial consistency and identifying standard case report form modules.
•    May support the creation of SDTM datasets, which may include oversight of external vendors.
•    Maintain current knowledge of relevant issues related to data management, Health Authority regulations, and competitive trends to provide input and recommendations.
•    May propose, draft, and maintain relevant Standard Operating Procedures and other policies and procedures relevant to the department; may participate in systems selection and implementation activities. 
•    International travel may be required. 
•    Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics. 
•    Other duties as assigned.

QUALIFICATIONS:

•    Bachelor’s degree in a scientific, medical, computer science or related field; Master’s degree preferred.
•    A minimum of 4 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of experience. 
•    Strong experience in data management-related activities, with thorough understanding of clinical trials process and regulatory requirements, including CDISC requirement, specifically SDTM Mapping.
•    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.
•    Experience in CRO management.
•    Ability to be hands-on with database 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.

The base salary range for this role is $115,000 to $155,000 CAD; we will consider above this range for exceptional candidates. Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.