Job Detail

JOB DESCRIPTION

Job Description

Our Clinical Research 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.

Main roles&Responsibilities

Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.


• Gains an in-depth understanding of the study protocol and related procedures.


• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.


• Participates & provides inputs on site selection and validation activities.


• Performs remote and on-site monitoring & oversight activities using various tools to ensure:

o Data generated at site are complete, accurate and unbiased

o Subjects’ right, safety and well-being are protected

• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.


• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.


• Communicates with Investigators and site staff on issues related to protocol conduct,

recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.


• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.


• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.


• Supports and/or leads audit/inspection activities as needed

Competency Expectations:

• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.


• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.


• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.


• Hands on knowledge of Good Documentation Practices


• Proven Skills in Site Management including management of site performance and patient recruitment


• Demonstrated high level of monitoring skill with independent professional judgment.


• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.


• Ability to understand and analyze data/metrics and act appropriately

Behavioural Competency Expectations:

• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills


• Able to work highly independently across multiple protocols, sites and therapy areas.


• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.


• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.


• Demonstrates commitment to Customer focus.


• Works with high quality and compliance mindset

Requirement:

B.A./B.S. required with strong emphasis in science and/or biology

Min. 2 years of direct site monitoring experience in a bio/pharma./CRO preferred

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.

Who we are

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. 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 continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

5

Requisition ID:R4164