Clinical Research Manager

Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry we strive to be Always Ahead and work relentlessly to bring therapy to patients in need no matter where they live.

Our values are at the core of every action we take and we are committed to going above and beyond for the benefit of the patients we serve.

The Clinical Research Manager (CRM) is a key member of the country medical team and represents a primarily clinical research focused role managing postapproval studies including committed PMS (postmarketing surveillance) and ISS (investigatorinitiated study) in accordance with respective local laws and within Medison SOPs.

The CRM will be an expert on the clinical operation aspects under their responsibility and will ensure their knowledge is current and thorough striving for continuous innovation to fit in the evolving regulatory environment in Korea and ensuring future readiness.

You will support the Country Medical Director in creating the country data generation/publication and RMP strategy considering medical launch excellence and successful life cycle management fully in line with brand strategies and company objectives meeting predefined targets of the affiliate medical affairs department.

The CRM reports to the Country Medical Director.

• Work closely with the Country Medical Director Medical Affairs Manager and MSL to establish a medical footprint in the country.
• Communicate with different internal functions or partners to synchronize touchpoints with HCPs for optimized investigator experience.
• Reviews and gives operational input to study or PMS protocol coordinates review and approval process with MA representatives and in accordance with Medison SOPs and requirements of partner companies.
• Oversight of the CRO with quality & performance indicators timelines and compliance with Medison SOPs KRPIA and MFDS regulatory requirements.
• Plan study budget in line with company business planning cycle and manage payment to vendor and investigators while meeting key milestones.
• Coordinates communications between CRO and Medison medical and regulatory affairs and PV to ensure regulatory and/or institutional approval of study initiation and completion take place timely.
• Support local RMP preparation and implementation when includes safety data generation.
• Prepare audit/inspection and develop/review CAPA.
• Participate in special local initiatives as assigned.
• May assume additional responsibilities if needed depending on team situation (e.g. support or facilitates any patient early access programs (EAP) or educational patient support program (PSP)).
• Communicates KOL investigators insights that influence the development of medical strategies.
• Ensures legal excellence and compliance in all clinical research activities as per company SOPs and local regulations.

Requirements :

• A bioscience education background with a healthrelated degree in a healthrelated scientific field such as Veterinary Medicine Pharmacy Nursing Biology Biochemistry Chemistry etc. is required.
• Requires an experienced CTM (clinical trial manager) or CRM (clinical research manager) with at least 5 years in pharmaceutical/biotechnology and in a similar role.
• Strong clinical operational and regulatory knowledge
• Experience of managing postapproval study endtoend.
• Ideally worked for postNDA approval studies (e.g. registry PMS qualitative studies) in rare disease or highly innovative drugs/firstinclass medicines and has built solid contacts to top investigators in the country.
• Experience oversight CRO and plan/manage study budget.
• Experience working within or closely with medical affairs.
• Experience working with different healthcare stakeholders.
• Good understanding of local healthcare environment
• Previous experience of dealing with PMS recruitment challenges successfully and crossfunctionally during perilaunch period is desired.

Required Qualifications:

• Ability to understand and effectively communicate protocol and regulation aspects to both internal and several external stakeholders.
• Good pedagogical skills.
• Highly collaborative and team spirited working with local and international colleagues internal and external stakeholders and fostering strong client relationships
• Patient centric
• Excellent proactive listening skills
• Fluent in English with excellent written and oral communication skills and ability to apply medical content in English is essential.
• Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships.
• Works effectively in highly dynamic and changing environments displays agility and an incessant scientific curiosity.
• Highly engaging with HCP investigators and focused on and curious about their needs.
• Driven by analytical and scientific evidence.
• Integrity and compliance mindset
• Comfortable taking initiatives and learning from them (both successes and failures)
• Ability to work with senior members of Medison stakeholders health funds MOH etc.
• Excellent IT and digital capability skills to communicate effectively in a digital world.
• Mobile willing to travel within the country as needed.

Remote Work :

Yes

Employment Type :

Fulltime