The Clinical & Human Factor Program Manager (CHF-PM) is part of the Clinical & Human Factor group within the Medical Affairs Department . The CHF-PM has responsibility for generation of evidence supporting claims for Wearable Injectors.
He/she is responsible for developing, supervising, executing and reporting of studies (clinical trials and Human factors studies) in compliance with policies and procedures, to contribute to product development and during the product life cycle. He/she will represent Medical Affairs internally (core team level) and externally (customer communication).
- Writing and updating robust Integrated Medical Plan for assigned product (Wearable Injectors).
- Building study design.
- Contributing to task analysis, use FMEA, DFU building and validation.
- Contributing to developing evaluation of products (methods and capabilities) to assess usability, acceptance, preference.
- Establishing an appropriate budget and timeline for the study with input from the corresponding project core team.
- Manage suppliers and other internal/ external parties: Global Clinical Development group.
- Establishing investigational products specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally) and supervising the preparation of the corresponding products on time and in compliance with defined budget.
- Writing/reviewing study documents, as needed such as protocol, CRF, consent form, session guide, database, clinical study report.
- Assure IRB approval if needed and applicable.
- Maintaining study documentation into the central study file.
- Supervising the interface with data management and statistics in developing case report forms, managing data cleanup, and analyzing study data.
- Completing final study report and closing of study file, contributing to publication writing.
- Clinical studies may range from simulated use studies (employing a patient or health care worker to use the device in a simulated environment; e.g. Human Factor studies) to complex studies in human subjects that may include drug/device combinations.
The CHF-PM interacts with product core teams and members:
- Represents Medical Affairs in several core team and cluster handling new product development.
- Is accountable to the team leader for deliverables.
- Leads the overall planning, leadership and execution of all activities.
- Provides work direction to the product safety and clinical development extended team members with regards to the project.
- Estimates resources requirement and identifies resources in conjunction with functional managers.
- Ensures deliverables produced meet the appropriate quality standards.
- Communicates progress and facilitates decision making with the core team and Medical Affairs function.
- Prepares and delivers presentations covering relevant Medical Affairs information (functional capabilities and clinical and HF study data) to customers during TC and face to face customer meetings The CHF-PM is responsible for assuring that study is conducted with HF guidelines (HF studies) and all National and Local Regulations.
- The CHF-PM participates in establishment and updating of the SOPs related to the C&HF development activities.
- Attend and complete assigned training courses concerning medical devices and human factors.
- It is expected that the CHF-PM acts as a leader of the department, and mentors other individuals formally or informally.
- Set an example with respect to work ethic, maturity, and adherence to Regulations and Guidelines, industry best practices, and guiding principles.
- Contribute to cross department and corporate initiatives, and to share their expertise.
- May be required to travel intermittently to achieve his/her routine responsibilities. He/she must be available for limited domestic or international travel as-needed basis within any C&HF study (mainly for study conduction in Europe, in USA, and potentially in Asia). Travel should not exceed 25 percent of his/her time.
Education and Experience Requirements
- Masters or PhD in Biological Sciences, or PharmD highly preferred.
- (Bachelor's in Biology or Life Science with 20+ years experience may be considered in lieu of Masters or PhD)
- Experience 4-6 years of clinical experience within the Pharmaceutical or the Medical device industry for PhD, PharmD or 10 years of clinical experience for MS, with good understanding and knowledge of Medical device environment (including design control); regarding applicable Quality / Regulation, a good understanding and operational knowledge of national regulations and a good understanding of international regulations are needed.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
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This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
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