Clinical Data Manager
Work Location - Home (West Coast Region)
Do you possess a mindset to accelerate Clinical Trials using Data and Analytics, do you believe in extreme disruption of the clinical data management and clinical operations process? If yes, Saama is looking out to hire you as we believe it should not take this long to get Drugs out to Market, we believe data and analytics powered by Machine Learning and Artificial Intelligence if put to proper use within Clinical Operations and Data Management organizations can bring significant time and outcome savings. We have re-imagined data-management processes and helped organizations significantly bring down the time it takes to lock a database by up to 95% for Vaccine studies, we don’t want to stop here, we want to recognize process inefficiencies in clinical operations and data management and disrupt them. We are firm believers in re-imagining data management and analytics, what we have done so far is just scratching the surface, a lot more has to be done with you on our team leading some of these transformational initiatives.

Clinical Data Management SME and serves as the main point of contact for customers to implement clinical solutions. You will work closely with Clinical trial sponsors, CROs at the executive and study team level to deliver Saama solutions to our customers.

Responsibilities

• Drive customer implementations to successful launch by providing data management inputs wherever necessary.
• Work with implementation resources, product, and engineering teams onshore and offshore to deliver innovative solutions to customers.
• Consult with business leaders to develop and understand the complex and diverse data management needs required for the project.
• Understand the role of the project in the clinical landscape and determine how changing business needs will affect the project.
• Collaborate with the customer and internal resources to understand usage and adoption trends and impact increased application use.
• Partner with Business development and customer success managers to implement solutions, estimate effort and help set customer expectations.
• Partner with Product Management to help align real-world customer feedback with the product roadmap.
• Perform the industry research to identify clinical development needs.

Impact on the business:

At Saama, our business is delivering solutions with world-class talent and services with most consultant satisfaction.

Key relationships:

• All project team members onsite offshore (in Pune, India)
• Operations support teams
• Client Relationships

Saama Competencies:

• INTEGRITY: we do the ‘right’ things.
• INNOVATION: we ‘change the game.’
• TRANSPARENCY: we communicate openly
• COLLABORATION: we work as one team
• PROBLEM-SOLVING: we solve core, complex business challenges
• ENJOY & CELEBRATE: we have fun

Competencies:

• Self-starter who gets results with minimal support and direction in a fast-paced environment.
• Takes initiative; challenges the status quo to drive change.
• Learns quickly; takes smart risks to experiment and learn.
• Works well with others; builds trust and maintains credibility.
• Planful: identifies and confirms key requirements in dynamic environments; anticipates tasks and contingencies.
• Communicates effectively; productive communication with clients and all key stakeholders Communication in both verbal and written communication.
• Stays the course despite challenges & setbacks. Works well under pressure.
• Strong analytical skills; able to apply inductive and deductive thinking to generate solutions for complex problems.

Requirements

• Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience.
• 10 years of industry experience working with EDC, IRT systems and integrations, third party data handling and other clinical systems implementation.
• Experience in Clean patient tracker, data review, missing pages, data quality checks, 3rd party data reconciliation and use of business intelligence tools like Cognos, Oracle, BI, Tableau, Spotfire, QlikView, Informatica.
• Familiar with clinical trial data and related workflows.
• Excellent understanding of common industry standard business practices related to clinical trials (study set up, study conduct, clinical operations process, data management review and reporting).
• Excellent at translating customer business requirements into enterprise solutions.
• Proven track record of driving customer success and operating at the executive and department levels within complex customer environments.

LSAC provides customers with the ability to leverage advances in technology, AI, and precision medicine to connect, contextualize, and analytically converse with all their drug development data assets. It accelerates time to market and positively impacts patient lives. The combination of Saama’s AI research, advanced technical & analytics capabilities, domain expertise across the drug development life cycle, and successful product co-development approach has made Saama a trusted partner and thought leader in the life sciences industry. Saama is committed to finding the best people because the innovations and discoveries that enabled together leads to better technologies, better treatments, and a better future

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment, including but not limited to, computers, phones, and photocopiers.

Physical Demands

This position requires the frequent and repetitive use of a computer, keyboard, and mouse. Hand and finger dexterity is required.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

EEO 

Saama Technologies, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.#LI-AG1