Job Description Summary: The Contract, Clinical Operations provides the scientific and operational expertise required to lead the execution of the complete life cycle of clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. The incumbent works as an integrated member of the clinical team to manage clinical trial(s) from study design through close out.
The incumbent works cross-functionally with internal departments and external resources on Clinical Operations related issues.
The Contract, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:ESSENTIAL FUNCTIONSPrimary duties/responsibilities:
- Performs as an integrated member of the clinical team to lead, direct and contribute to, the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting; recommends monitoring, safety, eligibility, enrollment, and data consistency strategies.
- Interacts with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables; meets with investigators and PTC scientific and clinical staff to obtain direction and feedback.
- Assists in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development; writes, reviews and/or edits study protocols, protocol amendments, study manuals, informed consent forms, and related documents.
- Prepares investigational site lists and participates in the review and approval of investigational sites; negotiates contracts and budgets with sites and vendors and presents to the project team for approval; plans, coordinates, and conducts investigator meetings including presentations at the meetings; responds to questions from sites and trial monitors regarding trial conduct.
- Manages clinical study timelines using the appropriate project management tools; develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors; presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings.
- Facilitates regulatory submissions and communications by working with appropriate team members during the submission process; writes assigned portions of reports for submission to regulatory agencies, institutional review boards, scientific journals, and conferences.
- Provides on-going review of clinical trial data to ensure timely, consistent, and accurate data; assists in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions.
- Compiles and reviews assigned portions of reports for submission to regulatory agencies and Institutional Review Boards (IRBs) and Ethics Committees (ECs).
- Addresses and resolves questions from sites and trial monitors regarding trial conduct.
- Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED* Minimum level of education and years of relevant work experience.
- Bachelor's degree in a scientific discipline and a minimum of 7 years progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, university medical center or related environment.
* Special knowledge or skills needed and/or licenses or certificates required.
- Comprehensive working knowledge of the drug developmental process.
- Working knowledge of clinical trial design, conduct, data acquisition, and reporting.
- Ability to recognize safety and efficacy trends of clinical data.
- Hands-on experience supporting and understanding Good Manufacturing Practice, (GMP), Good Clinical Practice (GCP), and International Conference on Harmonisation (ICH) guidelines.
- Ability to influence without direct authority.
- Proficiency with Microsoft Word and Excel.
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
- Prior involvement in Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
- Previous experience as a field monitor.
- Medical writing experience or training.
- Proficiency with Microsoft Project and Powerpoint.
* Travel requirements
Expected Hourly Range: $60 - $80/hour. The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
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