The Position

Takes ownership to deliver upon Clinical Development and Operations (CDO) goals, including successful delivery of trials. Responsible for site engagement by being the primary point of contact for site related issues. Drives study start-up, recruitment and retention on a site level to ensure site specific metrics are met. Contributes to improvement/innovation projects for CDO and/or as part of a global team and as aligned to a business case, goals and/or future aspirations. Contributes to a continually changing environment, supporting a future focused approach, leveraging competencies, tools and technology.

Relationships

Reports to the Manager (or above) within CDO. Builds and maintains strong relationships with external stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., clinical trial site staff, IRBs, clinical research vendors). Manage relationships with multiple internal stakeholders relevant to the execution of clinical trials and support of clinical trial sites (e.g., across CDO, CMR, International Operations (IO), HQ R&D and Commercial).

Essential Functions

• Site Support: Serve as the primary point of contact for clinical trial sites, offering guidance, support, and training as needed to ensure trial targets are met as well as protocol and regulatory compliance; triaging support requests to appropriate trial team members as appropriate; work closely with CRAs in overall site management
• Start-up: Performs site selection visits (SSV) as needed. Drives site activation through regulatory document collection, review, and tracking, including required study staff training completion and system access in alignment with trial start-up strategies
• Systems: Ensures study systems (e.g. COSMOS) are updated per expectations/requirements; Provides system expertise to train and support clinical trial sites, including managing system access; ensuring coverage of designated site communication systems (eg, central email "mailboxes")
• Execution: Track patient recruitment and assist with recruitment efforts by maintaining regular site contact; assist with patient retention oversight as per local strategy; assist with oversight of site EDC data entry and data query resolution
• Closure: Provides support to clinical trial sites during trial closure, including data cleaning/database lock and site closeout
• Quality: Provides support for trial and site audits and health authority inspections; assist the CRA with site Action Item and Protocol Deviation review and follow-up
• Development: Demonstrates technical proficiency within responsible areas, stays up to date on new processes, systems, and technologies while building knowledge of emerging trends and advances within area
• Collaboration: Contributes actively to Trial Core Team and other relevant teams

Physical Requirements

0-10% overnight travel required; May be required to work company holidays and weekends.

Qualifications

• A Bachelor's degree (science-related discipline preferred) or a Registered Nurse (RN) degree is required
• A minimum of 3 years of experience in the planning and conduct of GCP clinical trials, some of more recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical, biotechnology, CRO, and/or healthcare setting required
• A minimum of 2 years of direct expertise of site management and logistical execution of clinical trials required
• Relevant Novo Nordisk experience will apply where appropriate
• Site activation and site management/monitoring experience is an asset
• Demonstrated understanding of medical terminology and ICH-GCP principles and the application of those principles to trial planning and conduct of clinical trials
• Demonstrated computer skills (MS Office, clinical trial systems) and adaptability to new systems
• Excellent communications skills (verbal, written, presentation) in English
• Demonstrated collaborative and stakeholder management skills

This position is part of a job family. Title and level within the job family are evaluated based on a number of factors, such as years of experience, scope of work, proficiency, and business need. Candidates will be assessed for the most appropriate title and level within the job family during the recruitment process. The base range of pay for each title in this job family are as follows:

In-House Clinical Research Associate - $100,000 to $120,000

Senior In-House Clinical Research Associate - $115,000 to $150,000

In addition, this position is eligible for a company bonus based on individual and company performance.

Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.