Job Description:
Clinical Operations Manager-CLI003705 Description
MSD is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
MSD is a trade name of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A.
Accountabilities
- Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with CRD.
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
- Oversight and coordination of local processes. Clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Qualifications
Education & Experience
- Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- 2-3 years clinical research experience , Previous experience in clinical research required
- Requires expertise of core clinical systems, tools and metrics
- Excellent English skills required
- Strong coordination and organizational skills required
Additional Information to Evaluate the Job
- Has ownership, oversight and impact on local regulatory and financial compliance. Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the CRD. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Requires ability to make decisions independently with limited oversight from CRD. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
- Problem solving is essential to this position. 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.
- 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. Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English. The ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSD’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
MSD is an equal opportunity employer, proudly embracing diversity in all of its manifestations.
Job: Clinical Research Job Title:Clinical Operations Manager
Primary Location: EMEA-Russia-Moscow-Moscow
Employee Status: Regular
Number of Openings: 1
Additional Info:
[Click Here to Access the Original Job Post]
Clinical Operations Manager-CLI003705 Description
MSD is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
MSD is a trade name of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A.
Accountabilities
- Accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversight and tracking of clinical research-related payments. Payment reconciliation at study close-out. Oversight of FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with CRD.
- Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.
- Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
- Oversight and coordination of local processes. Clinical and ancillary supplies management, im- and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Qualifications
Education & Experience
- Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- 2-3 years clinical research experience , Previous experience in clinical research required
- Requires expertise of core clinical systems, tools and metrics
- Excellent English skills required
- Strong coordination and organizational skills required
Additional Information to Evaluate the Job
- Has ownership, oversight and impact on local regulatory and financial compliance. Able to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the CRD. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
- Requires ability to make decisions independently with limited oversight from CRD. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
- Problem solving is essential to this position. 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.
- 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. Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English. The ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.
- Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSD’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
MSD is an equal opportunity employer, proudly embracing diversity in all of its manifestations.
Job: Clinical Research Job Title:Clinical Operations Manager
Primary Location: EMEA-Russia-Moscow-Moscow
Employee Status: Regular
Number of Openings: 1
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]