Project Manager (Phase I 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.

Position would be ideally based in one 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. 


POSITION SUMMARY: 

Responsible for efficient and effective management for all phases of clinical projects.  Responsible for preparing project plans and leading the team members to complete projects on time, within budget and with the highest standards of scientific integrity.  Phase I experience desired.

 

PRIMARY JOB FUNCTIONS:

· Provides strategic direction to meet Project timelines/enrollment goals, data quality, Sponsor objectives, contractual obligations and budget oversight

· Supervises and maintains day-to-day project interactions with Clinical Team as well as Biometrics Team and other team members

· Participates as the facilitator in Team and Sponsor Meetings

· Communicates closely with Executive Directors, Senior Directors, Directors and Project Directors of Clinical Operations to resolve project and operational issues

· Contributes to the management and training of more junior Clinical Operations staff

· Works with Business Development and Proposals Department for sales presentations and bidding specifications

· Involved in interviewing and hiring resources, as needed

· Establishes and updates procedures and tools for training and development of department personnel and study teams

· In conjunction with Medical Affairs and Medical Management, develops protocol and design study, including appropriate project timelines based on experience and expertise in therapeutic area; reviews protocol for accuracy and develops any necessary amendments as requested by client

· Designs and/or reviews informed consent form

· Manages identification and recruitment of investigators; develops patient recruitment strategies and materials; negotiates investigator contracts as applicable

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

· Manages all aspects of the clinical projects including but not limited to the  development of the Project Plan, generating status reports monthly, developing cost budget and revenue forecasting, overseeing timelines, deliverables and resources, reviewing and signing off on Travel and Expense Reports

· Serves as team resource and primary contact for Sponsor

· Supervises Clinical Manger and Clinical Trials Associates on projects and ensures compliance with SOPs, GCPs and other regulations

· Attends and participates in internal and external training sessions

· Prepares for, attends, and facilitates as needed, project launch meetings, client meetings and Investigator’s Meetings

· Provides technical and therapeutic expertise to clinical staff

· Maintains ongoing awareness of developments in clinical research field

· Other projects as assigned

 

 

OTHER RESPONSIBILITIES:

· Must be available to perform up to 25% of overnight travel, as required

 

 

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

· Bachelor’s, Nursing (equivalent:  Registered Nursing Degree, i.e., R.N.), and/or Master’s degree in a biological- or science-related field required

· Excellent verbal and written communication skills

· Excellent interpersonal and listening skills

· Proficient computer skills including MS Word, Excel, PowerPoint, MS Outlook and some knowledge related to MS Project Timeline

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

· Ability to handle and prioritize multiple tasks in a fast-paced work environment

· Good presentation skills are required

· Knowledge of medical terminology, clinical pharmacology and pathophysiology

· Demonstrated working knowledge of the drug development process, 21 CFR, Good Clinical Practices, International Committee on Harmonization Guidelines and federal regulations pertaining to clinical research investigations

· Minimum of three (3) years experience in Clinical Management position such as Senior CRA and/or Clinical Manager, or equivalent

· One (1) to three (3) years previous experience as a Project Manager preferred

· Five (5) or more years of clinical experience in the pharmaceutical, biotechnology or CRO industry or equivalent is required

· Experience with one (1) to two (2) therapeutic areas required

· Experience with low-, medium- and high-complexity studies in Clinical Management position such as Sr. CRA and/or Clinical Manager- preferably to include Phase II-IV

· Minimum of 1 (one) year people management experience and demonstrated leadership and mentoring skills

· Experience in handling study budgets of at least $1 million

 

Click here to submit resume and salary requirementsIf you are unable to submit your resume electronically, please mail or fax your resume and salary requirements to:

 Human Resources
755 Business Center Drive
Horsham, PA 19044

Fax: (215) 907-1326