Clinical Operations Manager

Clinical Operations Manager

13 ene
|
Merck Gruppe - Msd Sharp & Dohme
|
Lima

13 ene

Merck Gruppe - Msd Sharp & Dohme

Lima

Location Panorama Plaza Office, Lima, Peru Job Type Full time

This site is for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific.

Residents of the United States, Canada & Puerto Rico, pleaseclick here.

Job Description

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.







Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to:

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).

Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.

Executes and oversees clinical trial country submissions and approvals for assigned protocols. • Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.

Manages 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 Headquarter to align country timelines for assigned protocols.

Provides support and oversight to local vendors as applicable.

Oversees and coordinates local processes, clinical and ancillary supplies management, importing 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.

Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.

Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.

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



Core competencies:

Expertise of core clinical systems, tools and metrics

Excellent English skills

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 SCOM or manager.

Ability to make decisions independently with limited oversight from SCOM or manager.

Requires strong understanding of local regulatory environment

Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.



Experience Requirements:

Required: 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Educational Requirements:

Required: Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience

Who we are …

We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continueInventing For Life, Impacting LiveswhileInspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

RegularRelocation:

No relocationVISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R91949



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About UsWe are one company, but we operate under two different corporate brand names.



We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else.

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This careers website is intended for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific.

Residents in the United States, Canada & Puerto Rico, please visit this Careers website .

Information on this site is for the purpose of presenting career opportunities at our organisation and give our audience a view of our culture, diversity and growth opportunities.

Our Company is an equal opportunity employer, proudly embracing diversity in all of its manifestations.

Reporting on our commitment to society, people and communities around the world

An initiative to create a world where no woman has to die giving life

The global animal health business unit of MSD

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