Job Vacancy Yerawada, Maharashtra Position FSP Clinical Scientist at サイネオス・ヘルス

Description

FSP Clinical Scientist

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 29,00 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

JOB RESPONSIBILITIES

• Perform medical and scientific data review on haematology clinical trials (indication anticipated myeloma or lymphoma)
• Standard data listing review (data listings, AEs, con meds etc)
• May complete patient profile review, standard listing data review, efficacy review and safety narrative review, PD analysis and PD review
• Will support Lead Scientist with scientific data review of clinical trial
• May support with additional CS tasks beyond scope of data review at the discretion of the Lead CS team however the primary role will be scientific data review
• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan). Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans.

• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews.

• Authors medical data queries and reviews query responses, approves query closure in association with Medical Director.

• May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed.

• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.

• Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review.

• Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.

• Attends at Trusted Process meetings and may participate in internal and external audits.

• Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology.

• Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans.

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline. Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment is essential. A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work. Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership. Understanding of scientific principles to assure effective and high-quality medical data analysis. Excellent written and oral communication skills. Excellent computer skills: MS Office programs, spread sheets, presentations. Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines. Strong team player with excellent interpersonal skills and ability to work effective in a cross-functional team environment.

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 73,00 Sites and 675,00+ 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

JOB SUMMARY Partners with Medical Director to provide clinical and scientific input to early and late-stage clinical development programs, with an emphasis on protocol-specific requirements, and ensuring the scientific integrity and data quality of clinical trials by using scientific knowledge. Collaborates with Medical Directors and other team members on data reviews and other Medical Management activities to ensure the successful execution and conduct of clinical trials.