Job Description:

Position Title:                  Senior Clinical Scientist

Department:                    Client Services

Reports To:                      Associate Director, Clinical Program Manager

FLSA Status:                   Exempt

Position Overview:

The Senior Clinical Scientist designs and executes clinical services to enhance clinical trials. The Senior Clinical Scientist partners with the sponsor clinical representatives to ensure appropriate project definition and ensures that clinical deliverables are in accordance with project scope. The Senior Clinical Scientist is responsible for evaluating data according to approved methodologies and presenting data reports to the sponsor.The Senior Clinical Scientist directly participates in attendance at face-to-face and virtual training events, and may participate in business development opportunities.

Essential Duties and Responsibilities: Other duties may be assigned.

Clinical Responsibilities

• Collaborates with study sponsors to establish appropriate project definition
• Reviews protocol/CRF and provides feedback as appropriate
• Designs and ensures appropriate execution of project specific processes and data review methodologies; ensures appropriate training
• Ensures development of appropriate clinical content (e.g., qualification methodologies, didactic presentations) for rater training and qualification programs for study staff in clinical trials
• Evaluates data submitted in accordance with Endpoint Reliability programs and contacts raters, as appropriate, to gather additional information and provide feedback
• Ensures that project clinical deliverables are in compliance with quality control standards
• Proactively identifies and escalates potential project issues appropriately to project team, sponsor and/or manager
• Communicates with study site staff in accordance with project specific methodology/SOPs and documents interaction in the respective IT application
• Ensures compliance with quality assurance as outlined in SOPs/Clinical Operations Guidelines
• Ensures consistency of product with actual project scope and resolves ambiguities in collaboration with both internal and external project teams
• Monitors performance of external Clinical Experts

 Management (Team Lead Only)

• Provides direct line management to Clinical Scientist, Clinical Specialist, Clinical Assistant
• Conducts appropriate supervisory meetings, and monitors productivity
• Ensures appropriate training and career progression

Business Development

• Participates in business development opportunities as assigned (e.g., client meetings, bid-defenses, preparation of materials)
• Attends conferences and scientific meetings as appropriate

Administration

• Submits weekly report of activity to manager
• Participates in orientation and training of staff as appropriate
• Participates on committees as assigned
• Completes required trainings in a timely manner
• Enhances the Bracket’s Client Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
• Ability to perform all responsibilities of Clinical Scientist, if required

 Skills & Competencies

Education

• Masters Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with three years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
• Bachelor’s Degree or RN with four years of clinical experience, which includes administration of psychiatric and/or cognitive scales

 Experience

• Minimum of one year as successful Clinical Scientist or equivalent

 Personal Attributes

• Excellent writing skills
• Demonstrated strong analytical, organizational, creative problem solving and communication skills
• Ability to succeed in a fast-paced, entrepreneurial environment
• Basic knowledge of statistics
• Competency conducting patient interviews
• Comfortable with being videotaped
• Competency working with data and numbers, understands basic statistical concepts
• Good negotiation and diplomacy skills
• Successfully manages own time, proactively identifies and prioritizes multiple tasks
• Ability to work with staff at all levels and across various disciplines
• Excellent computer skills including Word, Excel and PowerPoint
• Fluency in English (will be required to write, speak and understand English to conduct day-to-day business)
• Detail oriented
• Willingness to travel
• Willingness to maintain flexible schedule

Job Level: Mid-Senior Level

Start Date: 01/01/0000

Education Level: PHD

Industry:  Pharmaceuticals

Function:  Research, Science & Analytical

Skills Required: