Clinical Lead
Bracket 11 reviews - Wayne, PA

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The Clinical Lead participates in the development and delivery of clinical products/services related to clinical trials, such as training, surveillance, and cognitive testing. The Clinical Lead interacts with the sponsor to define the deliverables, and may directly participate in their execution through attendance at face-to-face and virtual training events.

Clinical Responsibilities

Develops project specific video material:
• Prepares project specific clinical content for study staff/patient education videos
• Conducts patient interviews and provides clinical feedback on interviews
• Prepares initial scoring rationale; coordinates scoring by clinical team based on acceptable score range guidelines
• Collaborates with Creative Services staff to edit video material to meet project specific criteria

Develops clinical content for training and qualification programs for study staff in clinical trials:
• Reviews protocol/CRF and provides feedback as appropriate
• Develops and ensures quality of project specific didactic presentations and other project specific clinical deliverables
• Attends internal and external kickoff meetings and project status meetings throughout the life of a project as required
• Attends Investigators’ Meetings to assist with direct execution of training as appropriate
• Develops protocol specific certification methodology
• Proactively identifies and escalates potential project issues appropriately to project team, sponsor and/or manager

Communicates with study site staff to address data quality issues:
• Communicates with study site staff in accordance with project specific methodology/SOPs
• Develops and ensures quality of project specific materials for efficient communication with study site staff
• Documents communication with study site staff in the respective IT application (e.g., RDA, IR2)

Manages reporting and analysis activities:
• Collaborates both internally and externally to ensure appropriate study design
• Develops reporting and analysis plans as appropriate
• Ensures that data-related issues are addressed (e.g., data queries, data amendments)
• Writes and QCs reports and other scientific text
• Ensures that data quality reviews are conducted as defined by project scope
• Ensures consistency of product with actual project scope and resolves ambiguities in collaboration with both internal and external project teams

Conducts remote scoring, interview assessment, and/or central rating:
• Conducts/reviews protocol specific scale interviews with patients (may require flexible schedule to accommodate time zone variations)
• Completes all required documentation within specified timeframe

Assists in training, development and retention of external Clinical Experts based on documented requests from Project Management:
• Participates in training and/or ongoing synchronization of external Clinical Experts (e.g., National Language Experts, Expert Presenters)
• Collaborates with external clinical resources and sponsor to ensure consistency with identified project scope and sponsor expectations
Initiates research activities:
• Prepares and submits poster presentations and journal articles under the guidelines of the Research Steering Committee and presents research at conferences as appropriate
• Submits weekly report of activity to manager
• Participates in orientation and training of staff as appropriate
• Participates on committees as assigned
• Enhances the UBC Specialty Clinical Services business model by institutionalizing business processes, implementing best practices, templates, and seeking ways to work more efficiently
• Supports business development activity as assigned by manager
• Ability to perform all responsibilities of Sr. Clinical Associate if required

• Masters Degree, M.D., Ph.D., Psy.D, Pharm.D., in healthcare-related field, with one year of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
• RN with 3 years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR
• Bachelor’s Degree in healthcare-related field with a minimum of two years of clinical experience, which includes administration of psychiatric and/or cognitive scales OR

• Minimum of one year clinical experience

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
• 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

We offer a highly competitive base salary and an outstanding benefits program, including medical, prescription drug, dental, vision, 401(k) with Company match, life insurance, and generous paid time off.

We are an Equal Opportunity Employer, M/F/D/V

About this company
11 reviews
Founded in 2011, Bracket is the union of United BioSource Corporation's (UBC) Specialty Clinical Services and Clinical Technologies...