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We are expanding our Clinical Data Management team with people who have drive, creativity, self-motivation, and professionalism. We are seeking an Associate Director for our Information and Data Management department with a minimum of 10 years experience and 5 years in leading DM projects.

Job Responsibilities and Requirements

• Participates in development, review, and revision of departmental procedural documents
• Provides training for DM staff
• Evaluates departmental practices with a focus on continual process improvement from a analytical and data quality stand point
• Participates in evaluation and application of DM resource allocation
• Oversees project EDC releases to ensure release requirements are met (standard reports, alert management, site and user activation and training, DM data review tools etc.)
• Other duties assigned by Director, Information Data Management

Oversee the implementation of the following activities on a project basis:

• 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 external data such as labs and IRT
• Define listings and reports for technical staff in terms of clinical data set variables
• Development of DM project activities timelines
• Preparation and maintenance of action item logs for DM projects
• Development and delivery in data sets in SDTM format
• Advocate for greater use of dynamic graph viewer in protocol compliance, data review, and cleaning activities
• Maintain awareness of and implement best industry practices per SCDM good clinical data management practices

Requirements

• Bachelors degree preferably in the sciences
• At least 5 years experience leading DM projects
• Minimum of 10 years experience in clinical research as a Clinical Data Manager or Clinical Research Associate
• Direct experience with hands on building EDC and validation check configurations
• 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.

Education and Experience

Bachelor’s degree. Experience in clinical research, biotechnology and/or healthcare industry required. Experience with the following eClinical product areas: Data Integrations, Data Analytics, eDC, Safety, eTMF, RTSM/IxRS, CTMS, 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; ensures the IDM team is meeting project 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.

Work Environment

This job is based in our Philadelphia HQ. Remote candidates will be considered.

Interested candidates are to send their CV to hr@prevailinfoworks.com

The Pharmacovigilance Analyst II will provide technical and process-related support to Prevail’s pharmacovigilance and medical monitoring activities, ensuring compliance with relevant global regulations and Standard Operating Procedures (SOPs).

Responsibilities:

• Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
• Electronic documentation and filing of safety information according to SOPs and safety management processes
• MedDRA coding of data in the safety database
• Preparation of case narratives
• Reconciliation of the clinical and safety databases
• Provide support for regulatory submission preparation and review
• Coordinate safety project setup, including safety database build
• Author sponsor/project specific safety management plans
• Conduct and assess literature searches
• Participate in sponsor/investigator meetings as required
• Maintain a working knowledge of the safety database
• Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
• Perform other duties as assigned

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.

Job Qualifications

Knowledge and Experience:

• Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices). Nursing experience is a plus.
• Proficient in MS Office and Adobe Acrobat
• Good Understanding of MedDRA & WHODrug Global dictionaries
• Must display analytical and clinical skills
• Requires narrative writing skills

Education:

Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience

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.

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.

This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. We are looking for a seasoned CRA that will be able to work with multiple indications including, CNS, specifically Alzheimer’s and Parkinson’s disease. Performs all tasks routinely and independently, seeking guidance as needed.

Essential Duties and Responsibilities

• Performs site qualification site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects/patients according to the protocol.
• Verifies issues or risks associated with blinded or randomized information related to IP.
• Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released/returned.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention, and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals / targets.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study.
• Verifies site compliance with electronic data capture requirements

Additional responsibilities include:

• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff
• Identify and communicate out of scope activities to Lead CRA/Project Manager
• Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations

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.

This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.

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.

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills and be able to embrace new technologies

Excellent communication, presentation, and interpersonal skills

Ability to manage required travel of up to 65% on a regular basis

Education and/or Experience

BS/BA, (MS/MA is desirable) in a health-related field

Must have strong customer service orientation and be a proactive and effective communicator. Excellent interpersonal skills are imperative.

Knowledge of basic computer programs such as Word, Excel, Power Point, MS Project, and Visio.

Work Environment

This job is a contract position.

This is an entry level position.

Our ideal candidate is a professional to perform well in a team environment in the two most lucrative industries, healthcare and technology.

Responsibilities

• Update and keep records
• Research and qualify companies
• Provide troubleshooting assistance
• Stay up-to-date review project records
• Provide data to help the Business Operations
• Manage tracking tools and report on important information
• Liaise with accounts
• Be process oriented
• Competitor research
• Provide data to support your colleagues

Do your interests include?…

• Teamwork
• Working alongside high achieving colleagues
• Work that appeals to your numbers skills

Prevail InfoWorks is a great workplace for anyone, with unique advantages for those just starting out their career. We have had great success giving students and recent graduates opportunities with our company.

This job is based in our Philadelphia, PA headquarters. Job will be performed in office.

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.

This is an equal employment opportunity and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status.