Study Start Up and Regulatory Affairs Specialist

2 mesi fa

Roma, Italia Ergomed A tempo pieno

Company Description

Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient’s lives.

**Job Description**:
**We are looking for someone who can speak French and/or German**

Provides Study Start-Up Specialist activities in support of assigned projects including **regulatory submissions, informed consent review, site contract/budget negotiation, essential document collection and review in preparation of site initiation and activation.**

Provides leadership to junior department and project team members.

**DUTIES AND RESPONSIBILITIES**:
Work closely with project teams to ensure efficient start-up processes for assigned projects in accordance with ICH-GCP, relevant Standard Operating Procedures (SOPs) and/or Sponsor-specific requirements.

May act as Study Start-Up Specialist Lead at project level; may directly interact with customers and sponsors as required. May serve as main point of contact for all project-specific Study Start-Up Specialist activities.
- Support the Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelines are not reached, provide clear rationale for delays and contingency plans to mitigate impact. Anticipate and identify site issues during start-up process and resolve minor to moderate issues independently.
- Provide support to Site Contract Lead to agree on country/site
- template contract and budget. Provides support in negotiating budget and contract with site until resolution of issues and contract execution.
- Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
- Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development and regulatory/EC submissions/approvals.
- Participate in ICF development, review, negotiation and approval processes.
- Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation and site initiation.
- Attend project team meetings and training sessions according to project and/or Sponsor requirements.
- Arrange for and/or review translation of essential documents as required.
- Assist with feasibility and site identification activities as needed.
- Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.
- Assist with mentoring and training of department staff and new-hire

**Qualifications**:
French and/or German language skills.

Bachelor’s degree (BA/BS) in a science-related field preferred or equivalent combination of education, training and experience.
Experience working the pharmaceutical, biotechnology or CRO industry and knowledge of clinical trials process required.
Previous experience in Study Start-Up and site contract negotiation.

Excellent oral and written communication skills.
Excellent interpersonal and organizational skills with strong attention to detail.
Good customer/client relationship management and proactive problem-solving skills.
Knowledge of the principles, methods, and procedures of clinical research.
Good computer skills including MS Word, Excel, PowerPoint, Outlook.
Experience with ICH/GCP documentation and process preferred.
Ability to assess, coordinate, and organize/reorganize workload of multiple projects in accordance with project priorities/assignments and timelines with focus on execution.

Additional Information

We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology. This is an ideal position to continue developing a career in clinical drug development.

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, gen

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