Clinical Manager (infectious disease experience)

Premier Research is a leading solutions-driven CRO leveraging our commitment to therapeutic focus and scientific expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies. Our teams evaluate the unique needs of each client and provide solutions catered to their specific project requirements.

Premier Research is committed to providing the best mix of clinical research services to meet the needs of pharmaceutical and biotechnology companies. We offer a comprehensive selection of services, including dedicated clinical sites, clinical trial management, medical and safety management, data management, biostatistics, medical writing, interactive voice response systems, regulatory affairs and quality assurance.



From protocol design and feasibility assessments through final study report, Premier Research excels in providing expert project teams for clinical trials. Using project management and reporting technology combined with expert data management and statistical analysis, Premier Research delivers consistent, quality results to help move your drug through the development process quickly and efficiently.

Our Clinical Manager will be responsible for working directly with a Project Manager or more Senior Manager within CTM to assist with the daily management of Phase I- Phase IV clinical studies in multiple therapeutic areas. Ensures that the clinical study is conducted in accordance with all protocols, rules and regulations.  Infectious Disease experience desired.

Position would be ideally based in any of our offices: Austin, TX; Hartford, CT; Philadelphia, PA; San Diego, CA; Boston, MA or Tampa, FL. Regionally based candidates, with experience, may be considered. 



PRIMARY JOB FUNCTIONS:

 

· Assists Project Management in the development and review protocol/study design, case report forms, informed consent forms and other documents

· Participates in the identification and recruitment of investigators; develop patient recruitment strategies and materials

· Coordinates Clinical Monitors on-site and in-house monitoring responsibilities, schedules and overall project related day-to-day management of the monitoring team

· Manages aspects of the clinical projects including development of the Project Operations Manual (POM) and the Clinical Monitoring Plan (CMP) and the review and sign-off of monitoring reports (including tracking of reports and assurance of visit frequency per CMP/contract; assists in preparation of the monthly status report

· Prepares source documentation and assist in generation of CRF guidelines

· Identifies, recruits and manages central lab, ECG, ABPM, drug labeling, packaging and distribution, Holter, IVRS as required per project scope

· Supervises Clinical Assistant(s) assigned to project teams for project related scope

· Ensures study master files comply with SOPs, GCPs and other regulations

· Prepares for and attends project team meetings and provides updates of project performance

· Designs and develops investigator, regulatory, operations, guidelines and training manuals

· Prepares for and attends project launch meetings

· Prepares for and attends client meetings; provides follow up with client regarding any study issues as requested by Project Manager

· Assists in the preparation and development of materials for the Investigators’ Meeting.  Attends Investigators’ Meeting and present assigned topics; serves as the primary clinical representative to investigative site research staff

· Attends and participates in internal and external training sessions

· Contributes to Business Development by attending meetings with potential sponsors; contributes time and cost estimates (and/or reviews draft proposals for feasibility) for CTM-related activities

· Provides financial management for the CTM portion of assigned projects as delegated by Project Manager and assists the PM by providing monthly updates on CTM's progress and performance with the project

· Monitors the preparation and timely completion of all regulatory filing packages and monitoring trip reports and reviews them for appropriate content

· In conjunction with the Project Manager or Project Director or as delegated, provides study-specific training to CTM personnel

· Perform additional duties and assignments as requested

 

OTHER RESPONSIBILITIES:

· May perform direct Project tasks, such as site monitoring, if needed, and on a routine basis based on project expectations and/or status (i.e., query resolution/database clean time, non-compliant sites, high-enrolling sites, etc.)

· Must be available to perform up to 33% overnight business travel, as required

 

 

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

· Bachelors’ degree (BS, BA, or RN equivalent) required; biological- or science-related field preferred

· Experience with three (3) to five (5) therapeutic areas required

· Three (3) to five (5) years of clinical monitoring experience, two of which as a Senior CRA

· Three (3) to five (5) years experience with Phases I – IV clinical trials

Three (3) to five (5) years of clinical experience in the pharmaceutical, biotechnology or CRO industry or equivalent is required

· Excellent communication skills (verbal, written and interpersonal)

· Good computer skills including MS Word, Excel, PowerPoint, MS Outlook

· Ability to work independently as well as part of a project team

· Able to handle and prioritize multiple assignments in a fast-paced work environment

· Good presentations skills are required

· Knowledge of medical terminology, clinical pharmacology and pathophysiology is required

· Proficient Regulatory Document review for IRB submissions

· Demonstrated good working knowledge of the drug development process, Good Clinical Practices, International Committee on Harmonization Guidelines and federal regulations pertaining to clinical research investigations

· Demonstrated leadership and mentoring skills desired

 

 

Please forward your CV and salary requirements via email to jobs@premier-research.com

 

Premier Research Group

755 Business Center Drive

Horsham, PA 19044

215 907 1326 fax

www.premier-research.com

jobs@premier-research.com