Clinical Operations Manager

Вакансия № 23158801 от компании ООО MSD Pharmaceuticals на Электронной Службе Занятости Населения Москвы.

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☑ Основной блок:

Опыт работы: 3–6 лет.

Тип занятости: полная занятость.

График работы: полный день.

Зарплата: по результату собеседования.

Примерное место работы: Россия, Москва.

☑ Актуальность объявления:

Это объявление № 23158801 добавлено в базу данных: Суббота, 25 января 2025 года.

Дата его обновления на этом интернет-ресурсе: Воскресенье, 16 марта 2025 года.

☑ Статистика предложения работы № 23158801:

Прочитано соискателями - 97 раз(а);
Отправлено откликов - 0 раз(а);

☑ Репутация компании "ООО MSD Pharmaceuticals":

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☑ Подробности о вакантном месте:

MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Do you want to help MSD become the world’s best healthcare company – while unleashing your own full potential? Are you the person with extensive experience in clinical research operations and experience with project management who is interested in making the difference?

Then you could be our new Clinical Operations Manager driving Start-up Cycle time for MSD Russia, Clinical Research department.

Your responsibilities

Work closely with the Senior COM and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials to support and manage the pipeline and local business needs to agreed timelines and budgets. Coordinate and liaise with Clinical Research Manager (CRM), Clinical Trials Coordinator (CTC), Clinical Research Associate (CRA), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRA) and local milestones. Collaborate closely with Regional Operations and Headquarter to align country timelines for assigned protocols. Provide support and oversight to local vendors as applicable.
Develop local language materials including local language Informed Consents and translations. Execute and oversee clinical trial country submissions and approvals for assigned protocols.
Develop, negotiate and complete CTRA. Oversee and track clinical research-related payments. Payment reconciliation at study close-out.

Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.

Your qualification:

Soft skills

Strongest focus on and personal accountability for results delivery, pro-activeness;
Excellent communication and influencing skills, high personal credibility and energy;
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Senior COM or manager;
Analytical, problem solving skills, out-of-the box thinking;
Problem solving is essential to this position.

Education & experience

Master's Degree. Preferable in Medicine/Life Science or equivalent experience;
5 + years of experience in clinical research;
Position requires extensive experience in clinical research operations and experience with project management and coordination.
Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements is essential.

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.