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.
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. MSD Research Laboratories 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.
As a Clinical Operations Manager (COM) in Denmark, you will be accountable for performance for assigned protocols in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally.
This is a very important role that has ownership of local regulatory and financial compliance and has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up phase.
As a Clinical Operations Manager your main responsibilites will be execution and oversight of clinical trial country submissions and approvals (including development of local language materials / local informed consents and translations) in addition to financial tasks related to Clinical Trial Research Agreements (bugdets and contracts).
In a Clinical Operations Manager role you be responsible for the country deliverables, timelines and results for assigned protocols to meet country commitments, and also for quality and compliance in assigned protocols in a country.
You will work in close collaboration with a Clinical Research Manager, Clinical Trial Coordinators, Clinical Research Associates (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. In addition, there’s also very tight interaction with Headquarter to align country timelines for assigned protocols.
As you can see, your tasks as a Clinical Operations Manager in Denmark are many and varied. They also include:
- Overseeing and coordinating of local processes, clinical and ancillary supplies management,
- Electronic filing and entering/ updating of clinical and finance systems.
You will report to Senior Clinical Operations Manager in Norway/Denmark This is an office-based position located in our Copenhagen office.
You understand science – and people
You understand science – and people
You have mininmum Bachelor’s Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience.
You have experience in clinical research, and if you have combined experience in Clinical Research and Finance/Business – this is highly preferable
Excellent written and oral communication skills in Danish and English are essential.
Other critical skills and competencies include:
- Expertise of core clinical systems, tools and metrics
- Strong coordination and organizational skills
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the Senior Clinical Operations Manager.
- Strong understanding of local regulatory environment
- Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills
- Ability to focus on multiple deliverables and protocols simultaneously is essential
- Ability to work effectively also in a remote virtual environment with a wide range of people.
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.
Application and further information
Start the application process by clicking the application button. Application deadline is June 5th, 2019.
Questions and further information regarding the position can be addressed to Kjersti Stærkebye, Senior Clinical Operations Manager Norway/Denmark by phone: +47 322 07 462.
About MSD in the Nordics
For over 125 years and counting MSD has revolutionised global health care. Today, more than 800 people work for MSD in the Nordics alone. Innovation is our life’s blood, and you will be a part of developing new and customer centric health care solutions that go beyond medicine to help people be well and live better lives during treatment. We have a strong pipeline of products within medicines, vaccines, biologic therapies and animal health products. We work every day to make healthcare accessible to as many as possible, which requires top talent within both R&D, marketing, finance, health economy and policy shaping. Globally, we operate in 140 countries and demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit http://www.workforlife.com
Job: Clinical Research – Clin Ops
Primary Location: EMEA-Denmark-84-Copenhagen
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD