Careers

CLINICAL DATA MANAGER

We are expanding our Clinical Data Management team with people who have drive, creativity, self-motivation, and professionalism. We are seeking Clinical Data Managers with a minimum of five years’ experience.

Job Responsibilities

• Define eCRF specs from a protocol
• Build eCRFs in EDC
• Define and build data set specs
• Define edit checks/validation specs
• Write and execute data management plans
• Clean and query data, and manage site/CRA follow up
• Manage reconciliations with externa data such as labs and IRT
• Define listings and reports for technical staff in terms of clinical data set variables

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor’s degree preferably in the sciences
• Minimum of five years’ experience in clinical research as a Clinical Data Manager or Clinical Research Associate
• Experience in vaccine studies is a plus
• Experience with integrating data from eSource into EDC systems is a plus
• Great communications skills, both verbal and written, remotely and in-person
• Organized and detail-oriented for improving data management processes
• Ability to work as a team for organizational success
• Experience with one or more of the following eClinical product areas: Data Integrations, Data Analytics, EDC, Safety, eTMF, RTSM/IxRS, CTMS, SDTM, or Investigator Grant Management. Proficiency with Microsoft Office Tools (Excel-Spreadsheets, Word, PowerPoint).

Competencies
To perform the job successfully, an individual should demonstrate the following competencies:

Ethics – Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Customer Service – Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.

Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.

Professionalism – Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

Skills

• Biotechnology
• Clinical Data
• Clinical Trials
• Data Management
• Analytics
• Customer Service
• Electronic Trial Master File (eTMF)
• Data Integration
• Data Analytics
• SDTM

Other
As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

CLINICAL DOCUMENTATION ASSOCIATE

The Clinical Documentation Associate is responsible for providing support to the TMF Manager and Clinical Operations personnel to ensure quality clinical trial documentation is being collected and filed for the purposes of regulatory and health authority inspections; and to ensure compliance as delegated by trial sponsors and under applicable institutional policy.

Job Responsibilities
Department tasks

• Provides administrative and workflow support to the TMF Manager as needed to ensure rolling health of client eTMF systems.
• Coordinates ad hoc meetings on behalf of the TMF Manager and generates/circulates the associated meeting minutes where necessary.

Project tasks

• Acts as point person for receipt of documents to be submitted into the study-specific eTMF from the document originator.
• Conducts initial compliance reviews of documentation upon receipt to ensure contextual applicability of the materials.
• Submits documentation into the respective study-specific eTMFs and assigns document metadata such as document date, SOP reference, and expiration dates (as applicable).
• Maintains oversight of gaps in documentation and generates reports for fulfillment and oversight, as needed.
• Travels as necessary, consistent with project and supervisory needs.
• Other responsibilities as assigned by the TMF Manager or senior Clinical Operations personnel.

The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Willingness to learn a specialized skillset in a niche aspect of pharmaceutical trials.
• Excellent organizational skills and attention to detail.
• Ability to work well within a team and establish effective relationships across all levels of the organization.
• Strong computer skills (MS Office), SharePoint, and Acrobat.
• Aptitude to learn additional software programs and databases.
• Knowledge of clinical trial design, execution, and operations a plus.
• Experience utilizing Electronic Trial Master File systems and the DIA TMF reference model a big plus.

Education and/or Experience
Associate’s degree or an International Equivalent in Computer Science, Life Science, Health Sciences or Information Management or Related Field or the equivalent of relevant experience. Higher level degrees preferred but not required.

Language Skills
Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

Other
As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.

SALES SUPPORT REPRESENTATIVE

Our growing team is seeking an enthusiastic detail-oriented individual to perform administrative tasks for our sales team. It helps to be someone who takes initiative, thinks creatively, can juggle multiple tasks successfully, and is confident setting and meeting time sensitive deadlines. Someone who can keep things organized, enjoys collaboration, and is interested in learning about supporting customer acquisition (sales). Prevail works in life sciences however relevant past experiences will be considered regardless of life science industry experience. If this description and the details below sound like a fit for you, please send us your cover letter and resume.

Job Responsibilities

• Conference and prospect research
• Administrative support
• Email inbox management
• Scheduling meetings for executive management
• Follow-up phone calls
• Reminders
• Calendar management
• Data entry
• Data maintenance/scrubbing
• Managing and lead routing
• Drafting post meeting deliverables
• Other responsibilities as needed

The ideal candidate should be extremely detail-oriented, capable of multi-tasking, and thrive in a fast-paced, collaborative, and dynamic workplace.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Proficient in CRM databases
• Excellent written and verbal communication skills
• Great attention to detail
• Great communication skills
• Strong time-management skills
• Experience with the Microsoft Office Suite
• Work independently and collaboratively with sales associates to codify lead records and facilitate leads follow up.
• 1-4 years’ work experience required
• 1-2 years sales experience preferred

Benefit

• Commission pay

CLINICAL PROJECT MANAGER

We are expanding our Clinical Safety team with people who have drive, creativity, self-motivation, and professionalism. We are seeking a Clinical Project Manager with a minimum of 2 years of experience.

The Clinical Project Manager (PM) is responsible for independently managing multiple clinical trials. The PM is expected to address site and vendor related issues, with assistance as needed. They are also responsible for managing the entire project life cycle including defining requirements; writing project specifications; project implementation; project execution; change control and project close while providing the client with a single contact.

Job Responsibilities

• Manages clinical trials assigned
• Manages outside vendors such as monitoring CRO, diagnostic companies, stats contractors, meeting planners, drug depots etc.
• Contributes to the development and management of budgets, timelines and quality guidelines for projects, thereby ensures that expectations are met while identifying and mitigating risks
• Compiles and drives documentation for the project, ensures the accuracy and quality of regulatory data
• Ensures clinical trials are effectively executed and completed within budget, timelines and meeting enrolment commitments as well as routine updating clinical systems
• Leads proactive trial management to identify challenges, develop effective mitigation plans and to appropriately escalate and inform all relevant parties
• Ensures management of trials are done in compliance with ICH, GCP, global standards, local laws and regulations
• Supports client communications with status reporting, agenda, minutes and changes orders
• Reviews protocols and assists with development of project plans, DMPs and monitoring plans
• Monitors all study activities
• Demonstrates a sense of professionalism. Provides proactive and creative recommendations on how to meet goals and handle identified deviations.
• Develops project status reports and communicates with all applicable team members in and outside the organization.
• Initiates improvements to enhance the efficiency and the quality of the work performed on assigned projects.

Job Qualifications

• Minimum of a bachelor’s degree with a major in science, nursing, or other health related field is required. Advanced degree desired.
• Minimum of 2 years progressive clinical project management experience is required.
• Experience serving as study coordinator, CRA, or clinical trial assistant desired.
• Must have customer service orientation and be a proactive and effective communicator.
• Excellent interpersonal and teamwork skills are imperative.
• General knowledge of all applicable regulations (GCP, FDA, OHRP, HIPAA).
• Demonstrated proficiency with all Microsoft Office Tools.

Supervisory Responsibilities
Direct supervision of all support staff assigned on a project basis. This includes cross-functional services such as supplies and logistics, data management, Pharmacovigilance, TMF managers, and software engineers and designers.

Language Skills
Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers.

Reasoning Ability
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities.

Other
As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.