Clinical Operations Manager
il y a 3 semaines
**Location: home-based**
**Who we are?**:
Optimapharm is a leading, mid-sized, **full-service CRO working across Europe and North America** to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.
With **27 strategically located offices**, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.
In-depth expertise and long-standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
We are looking for a **Clinical Operations Manager (COM)** to join our team and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
**What do we offer?**:
- Working in a successful company that’s growing and changing every day
- Working with a highly experienced team of the clinical research professionals
- International projects and professional growth
- Performance bonus
- Training opportunities
- Flexible work hours
- Summer work schedule
**Who are we looking for?**:
**Qualifications and** Experience**:
- University degree in medical or life sciences (or equivalent in experience required).
- A minimum of **5 years of clinical research** or other relevant experience is required.
- ** Experience **in **mentoring and supporting CRAs and CTAs**:
- ** Experience **with **audits and inspections**:
- Experience with accompanied or clinical quality-controlled visits with CRAs
- Experience with Quality Check of TMF/eTMF
- Shown ability to communicate with internal and external partners in an efficient and professional manner
- Excellent knowledge of GCP and ICH Guidelines and ISO 14155 norm
- Excellent knowledge of relevant international and local regulatory requirements concerning the conduct of investigational medicinal product and investigational medical devices studies
- Excellent organizational and planning skills
- Excellent interpersonal, written, oral, and administrative skills
- Ability to work in a fast-paced, team-oriented environment
- Computer proficiency is mandatory
- Fluent in the local language and English, both, written and verbal
**Your **responsibilities**:
- ** Lead, manage, and support the assigned members of the Clinical Operations teams** (including both employees and contractors) and processes to ensure that OPTIMAPHARM delivers quality projects to its Clients within agreed project targets and time ensuring that expectations are met
- ** Support the Clinical Operations Director (COD)** to ensure that country project targets are met by the assigned team
- ** Supervise and assess the performance of team members and motivate, train, and develop the team's expertise** to ensure efficient and effective day-to-day operations
- Collaborate with COD to **ensure proper allocation and utilization of staff on projects** in the countries they are operating in
- ** Focus on the development, performance, and quality of the assigned Clinical Operations team**:
- Perform Accompanied visits and Clinical Quality Controlled (CQC) visits with CRAs, periodic Quality Checks of TMF/eTMF and contribute to Quality initiatives from the QAT department
**By joining our fast-growing and prosperous team, you will have a great opportunity for further personal growth and career development.
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