Central Monitor Ii

4 days ago

Remote, India Syneos - Clinical and Corporate - Prod Full time

**Description**

**Central Monitor II**

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

**Job responsibilities**
- Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
- Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.
- Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
- Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
- For assigned activities, understands project scope, budgets, and timelines; manages patient
- and site-level activities to ensure project objectives, deliverables and timelines are met.
- Must be able to quickly adapt, with the oversight of the Lead CRA/LCMDA, to changing priorities to achieve goals/targets.
- Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings, as applicable and attends clinical training sessions according to the project specific requirements.

**Qualifications**

**What we're looking for**
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Mastery of MS Excel (sorting, filtering, calculating, pivoting).
- Proficient with Analytical Data Visualization Tools (adjusting visualizations, selecting subsets of data to analyze).
- Excellent verbal and written communication skills to relate to internal stakeholders. Able to inform, influence and communicate cross-functionally.
- Strong analytical skills.
- Developing therapeutic expertise.
-

  • Central Monitor Ii

    2 weeks ago

    Remote, India Syneos - Clinical and Corporate - Prod Full time

    DescriptionCentral Monitor IISyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of...

  • Central Monitor I

    2 weeks ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Central Monitor I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

  • Site Monitor Ii

    2 weeks ago

    Remote, India ICON Full time

    As a Site Monitor II (CRA) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing:The Site Monitor will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in...

  • Cra I

    2 weeks ago

    Remote, India Syneos - Clinical and Corporate - Prod Full time

    **Description** **Clinical Research Associate I / **Clinical Research Associate II (Mumbai Location)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our...

  • Biostatistician II

    1 day ago

    REMOTE, India Parexel Full time

    Position Summary:The Biostatistician II is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a...

  • Field Technician Ii

    2 weeks ago

    Remote, India Zayo Group Full time

    Company DescriptionZayo provides mission-critical bandwidth to the world's most impactful companies, fueling the innovations that are transforming our society. Zayo's 141,000-mile network in North America and Europe includes extensive metro connectivity to thousands of buildings and data centers. Zayo's communications infrastructure solutions include dark...

  • Site Monitor Ii

    2 months ago

    Remote, India Parexel Full time

    **Key Accountabilities**: **Start-up (from site identification through pre-initiation)**: Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase. - Build relationships with investigators and site staff. - Conduct, drive and manage country specific feasibility and/or site...

  • Field Technician Ii

    4 weeks ago

    Remote, India Zayo Group Full time

    Company Description Zayo provides mission-critical bandwidth to the world’s most impactful companies, fueling the innovations that are transforming our society. Zayo’s 141,000-mile network in North America and Europe includes extensive metro connectivity to thousands of buildings and data centers. Zayo’s communications infrastructure solutions include...

  • Cra Ii

    4 weeks ago

    Remote, India ICON Full time

    As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **Responsibilities**: The Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the trial lifecycle. Key responsibilities include: - Full ownership of...

  • Cra Ii

    4 weeks ago

    Remote, India ICON Full time

    As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**Responsibilities**: - The Clinical Research Associate is ultimately responsible for the successful management of investigator sites - throughout the trial lifecycle. Key responsibilities include: - Full ownership of...

  • Product Designer Ii

    2 days ago

    Remote, India Eventbrite Full time

    THE TEAM Design is a core part of our DNA at Eventbrite. We have a centralized design team that works in partnership with product managers and engineers to make a positive impact on our users’ lives and businesses. To that end, designers are embedded in product teams in order to get to know our users better, collaborate effectively, and focus diligently...

  • Central Review Manager

    4 weeks ago

    Remote, India ThermoFisher Scientific Full time

    Job DescriptionDescription Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM. Liaises with clinical monitoring staff for prompt trip report review submission and approval...

  • Central Review Manager

    1 month ago

    Remote, India ThermoFisher Scientific Full time

    Job DescriptionDescription Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM. Liaises with clinical monitoring staff for prompt trip report review submission and approval...

  • Solutions Architect Ii

    3 weeks ago

    Remote, India Akamai Full time

    **Would you enjoy working with cutting-edge web performance and security systems?** **Want to be a presales technical implementation and consulting expert?** **Join our cutting-edge Product Evaluation Team** The Product Evaluation team is a unique and fast paced centralized team with product experts who work closely with sales and customers to prove...

  • Product Designer Ii

    2 weeks ago

    Remote, India Eventbrite Full time

    THE TEAMDesign is a core part of our DNA at Eventbrite. We have a centralized design team that works in partnership with product managers and engineers to make a positive impact on our users' lives and businesses. To that end, designers are embedded in product teams in order to get to know our users better, collaborate effectively, and focus diligently on...

  • Solutions Architect Ii

    2 weeks ago

    Remote, India Akamai Full time

    Would you enjoy working with cutting-edge web performance and security systems?Want to be a presales technical implementation and consulting expert?Join our cutting-edge Product Evaluation TeamThe Product Evaluation team is a unique and fast paced centralized team with product experts who work closely with sales and customers to prove differentiated...

  • Study Start Up Associate Ii

    3 weeks ago

    Remote, India ICON Full time

    **At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.** **Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...

  • analyst, hris, ii

    10 hours ago

    Remote, India Qualfon Full time

    Job SummaryAs SAP SuccessFactors Technical Analyst you will participate on development delivery and maintenance of business solutions based on SAP technologies. You will capture functional and technical requirements from internal customers and translate business requirements in SAP requirements identifying the best solution. You will be responsible for...

  • Biostatistician Ii

    4 weeks ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Biostatistician II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the...

  • Senior Software Engineer II

    2 weeks ago

    Remote, India Precisely Full time

    Precisely is the leader in data integrity. We empower businesses to make more confident decisions based on trusted data through a unique combination of software, data enrichment products and strategic services. What does this mean to you? For starters, it means joining a company focused on delivering outstanding innovation and support that helps customers...