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Sr Clinical Operation Specialist / Lead Clinical Operation Specialist (immediate Joiner)

サイネオス・ヘルス
Pune, Maharashtra

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Job details

Qualifications

Clinical research
English
Communication skills

Full job description

Updated: Yesterday
Location: Pune, MH, India
Job ID: 25108746-OTHLOC-5580-2DR

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Description

Sr Clinical Operation Specialist / Lead Clinical Operation Specialist (immediate Joiner)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Job Responsibilities

7–10 years of relevant CTA experience
CTA experience combined with centralized monitoring exposure is preferred
Home-based position with immediate joiners strongly preferred
Strong operational understanding of clinical research
Good communication skills and fluency in English
Must be proactive, resourceful, and a quick learner
roles and responsibilities.
Support set-up and maintenance of information in Clinical Trial Management Systems and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager as applicable: Update data, timelines, milestones, Ethics Committee /
Health Authority authorizations, etc. on an ongoing basis.
Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.
Support set-up and maintenance of Trial Master File: Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.
Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).
Support in External Service Provider coordination:
1.Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out.
2.Follow-up with External Service Providers on day-to-day operations
3.Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues
4.Logistical support to study team (internal and external) onboarding process
Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.
Support CTT in study start-up activities, recruitment and close-out activities as required.
Champion the implementation of operational changes and transitions as required.
COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:
1. Responsible for developing monitoring plans and study specific tools as applicable
2. Provide input to eCRF design & review, and other documents and systems, as applicable
3. Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data
4. Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. to the clinical team and CRAs for timely follow-up of actions and issue resolution
5. Collaborate with Medical Lead to identify any safety trends, is a key team member of the ClinicalTrial Team and will lead the discussion in Data Review Team (DRT) meetings
6.Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visits

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Roles within Clinical Operations are responsible for ensuring safe and effective operations of clinical research studies. Responsible for safeguarding the wellbeing of research subjects in a medical capacity. Reviews study protocols, plans and executes procedures in alignment with protocols and regulatory, health, and safety standards, raising or escalating study issues. Recruits and coordinates communication with clinical trial volunteers and patients, and follows applicable regulations globally and by region. Collaborates with cross-functional teams to develop study materials, monitor trial progress, and address any issues that arise during the study. Impact and Contribution Individual contributors who provide organizational related support or service (administrative or clerical), as well as roles operating in support of daily business activities (e.g., technical, production, or craft levels). The majority of time is spent in the delivery of support services or activities, typically under supervision. Roles do not typically require advanced education or training. Established and experienced support individual contributor. Work consists of tasks that are typically routine, with some deviation from standard practice. Requires broad knowledge of operational systems and practices typically gained through extensive experience and/or education.

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roles and responsibilities.

Support set-up and maintenance of information in Clinical Trial Management Systems and other systems as applicable, independent or under the responsibility of (Sr.) Clinical Project Manager as applicable: Update data, timelines, milestones, Ethics Committee /

Health Authority authorizations, etc. on an ongoing basis.

Support (Sr.) CPM with study budget management, ensuring accurate planning, tracking and reporting of clinical study budget and Grant Plan as applicable. Perform Good receipt booking in line with Vendor financial report and study status, as required.

Support set-up and maintenance of Trial Master File: Ensuring that all key documents are present and filed as appropriate in TMF, independent or under responsibility of (Sr.) CPM as applicable. Follow up with Clinical Trial Team at agreed frequency for TMF maintenance.

Track clinical studies/projects/activities progress, ensure CTMS, TMF and other systems as applicable are up to date. Address questions; escalate issues or critical findings to project lead (Sr./CPM).

Support in External Service Provider coordination:

1.Support (Sr.) CPM in set up and coordination of External Service Providers, ensuring all information, documentation and material in place for clinical study/projects/activities at start, conduct and close-out.

2.Follow-up with External Service Providers on day-to-day operations

3.Ensure all data is reported to the Clinical Trial Team (CTT) and available to business colleagues

4.Logistical support to study team (internal and external) onboarding process

Support in meeting set up, coordination and meeting minutes, running reports from systems, draft project documentation.

Support CTT in study start-up activities, recruitment and close-out activities as required.

Champion the implementation of operational changes and transitions as required.

COS may additionally support below activities as deemed necessary by reporting manager or Head CPM:

1. Responsible for developing monitoring plans and study specific tools as applicable

2. Provide input to eCRF design & review, and other documents and systems, as applicable

3. Responsible for central monitoring and data oversight on assigned clinical study(s) using available online data sources (eCRF, IRT, central lab, etc.) to ensure consistency, plausibility, completeness and correctness of the data

4. Communicate any observations, deviations to protocol, safety alerts, quality issues, trend/patterns, risk factors etc. to the clinical team and CRAs for timely follow-up of actions and issue resolution

5. Collaborate with Medical Lead to identify any safety trends, is a key team member of the ClinicalTrial Team and will lead the discussion in Data Review Team (DRT) meetings

6.Prepare and share the Central Monitoring Package where applicable and agreed with the CRAs prior to monitoring visits