Job Description Summary:
The Contract, Clinical Operations Manager is responsible for providing the scientific and operational expertise required to conduct clinical trials in accordance with appropriate regulatory requirements for one or more indications within or across therapeutic areas. This includes, but may not be limited to, working as an integrated member of the clinical team to develop, implement, and manage clinical trial(s) from study design through close out. Manages relationships with external partners to ensure timelines and deliverables are met. As necessary, the incumbent also reviews, and may contribute to, the development of clinical study-related documents.
The incumbent works cross-functionally with internal departments and external resources on Clinical Research related issues.
The Contract, Clinical Operations Manager supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Reviews, and may also contribute to the development of, clinical study-related documents. This includes, but may not be limited to, study protocols, protocol amendments, study manuals, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Investigator's Brochures (IBs), Clinical Study Reports (CSRs), regulatory submissions and other documents as required.
- Helps to ensure that the study is conducted in accordance with agreed upon timelines.
- Prepares potential investigator site lists for study feasibility and assists with their evaluation and approval for inclusion in the study. Ensures essential clinical documents are in place for approved/assigned sites to ensure timely site initiation and patient enrollment.
- Contributes to the planning and coordination of investigator meetings. This includes, but may not be limited to, developing and presenting assigned sections of the meeting agenda/content.
- Maintains relationships with assigned investigator sites, vendors and consultants.
- Ensures investigator and investigator site personnel comply with protocols; recommends corrective action(s) as required.
- Assists in the oversight of the shipment of, and return of, clinical supplies (drug and non-drug) for assigned sites, as necessary.
- Maintains accurate and updated study files.
- Participates in the selection and oversight of external service providers, including Clinical Research Organizations (CROs) and other vendors as necessary. Contributes to, and participates in, budget development, contract negotiations and expenditure oversight.
- Recommends strategies for, and oversees, the execution of activities associated with. clinical monitoring, safety, eligibility, enrollment, and data consistency.
- Assists in configuration and implementation of study-related systems as appropriate (i.e. data management, study drug tracking, etc).
- 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 relevant discipline and a minimum of 4 years of experience in related clinical operations roles in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment OR equivalent combination of education and/or experience.
* Special knowledge or skills needed and/or licenses or certificates required.
- In-depth understanding of the drug development process.
- Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
- Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Excellent verbal and written communication and skills.
- Proficiency with Microsoft Word and Excel.
- 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.
- Previous clinical monitoring experience.
- Experience with Microsoft PowerPoint.
* Travel requirements
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EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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