Apply for Senior Director in Clinical Programming at Syneos Health @ Apply Now

Post : Sr Director, Clinical Programming

JOB SUMMARY 
This position is responsible for overseeing the delivery of Data Operations Technical Service team at regional level. Plans for the efficient allocations of resources and ensures delivery across all locations is effective, efficient and profitable. Maintain awareness of current developments and changing technology within the industry, recommends strategic technical solutions for business unit in coordination with IT and Data Management department leadership.

JOB RESPONSIBILITIES
• Oversees and manages resource management and maintains utilization/realization at regional level.  Ensures that all projects maintain the correct level of gross profit, budgets are maintained and changes in scope applied as necessary within assigned region.  Additionally, implements a project review process to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately.
• Contributes to the development of policies, procedures and standards for Data Operations Technical Services activities.  Ensures implementation and training of standard operating procedures for staff.
• Serves as primary interface between company and sponsors, vendors and other department in the area of Data Operations Technical Services.
• Regularly reviews all relevant projects for financial control and operational productivity. Provides operational metrics at regional level.
• Supports the achievement of Data Operations departmental sales, revenue, utilization and gross profit targets.
• Ensures compliance with Good Clinical Practices sponsor contracts as well as all Food and Drug Administration and International Conference on Harmonization requirements.
• Participates in the sales and marketing function as it relates to operational activities.  Provides input and review/approval of study proposals in the scope of Data Operations Technical Services tasks.
• Collaborates with senior management of pharmaceutical and biotechnology sponsors on operational issues and with other vendors as required.
• Ensure implementation of Data Operations Technical Services global strategy at regional level.
• Collaborates with senior management and contributes operational input to other departments as appropriate.
• Leads Data Operations initiatives throughout applicable departments within Biometrics Business Unit.
• Liaises with Human Resources department for execution of recruitment strategies at regional level.
• Serves as a primary source of operational information in the budgeting process for clinical programming, clinical coding and randomization services projects and department. 
• Serves as business owner of Data Operations departmental applications.
• Identifies, manages and oversees the business need for the strategic use of technology.  Selects and managers vendors and oversees the use of resources.
• Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences.
• May represent the Company at professional meetings or seminars.
• Line management responsibilities for staff members. For direct and indirect reports, may participate in and manage activities related to department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.  Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.

Candidate Profile
• Master degree preferred in computer science or related field, and extensive experience, particularly in design, development and implementation of clinical data collection systems targeted at supporting large-scale multiple site clinical trials with supervisory experiences required.
• Experience in a Contract Research Organization or Pharmaceutical/Biotechnology company is a plus.
• Experience working in a matrix structured environment with multiple product lines is essential.  In-depth knowledge of relevant regulations and strong understanding and usage of medical terminology.
• Excellent leadership/management skills with ability to handle multiple tasks to meet deadlines in a high stress environment.
• Effective organizational, presentation, documentation, analytical, Project Management and interpersonal skills with demonstrated ability to lead and motivate a matrix team.
• Proficiency in Word, Excel, and PowerPoint.  
• Ability to travel as necessary (up to 25%)

Additional Information
Qualification : Master degree
Experience : 5+ years
Location : Gurgaon/Hyderabad
Industry Type : Pharma
Functional Area : Clinical Programming
End Date : 30th April, 2019

Require Manager in Medical Writing at Syneos Health

Post : Manager, Medical Writing

Primary Function :
The Manager, Medical Information is responsible for providing line management to medical information staff, resourcing and ensuring deliverables to meet customer and internal goals.

Major Responsibilities:
• Position will be 75% technical and 25% into people management.
• Manage and oversee the preparation of medical information and disclosures, which includes managing medical information activities performed by staff writers and external information consultants.
• Assist with budgeting, revenue, invoicing and forecasting as requested.
• Review and edit documents or sections of documents prepared by other writers (internal or contractors).
• Ensure adherence to client objectives and that quality standards are maintained.
• Support the company's medical information leadership team in the planning, development and implementation of medical information and disclosures strategies.
• Build and maintain relationships with internal and external customers.
• Form, maintain, and lead productive cross-functional working teams, including addressing issues that arise.
• Develop templates and guidelines for clinical documentation and act as resource for implementation.
• Contribute to departmental metrics.
• Support medical information leadership with development and presentation of quarterly business updates.
• Develop and maintain departmental Standard Operating Procedures (SOPs) for scientific communications services.
• Support business development activities by assisting with proposal and costing development as well as bid defense and customer meetings.
• Assist in tracking, maintaining, and reviewing project metrics.

Candidate Profile
• Bachelor’s of Science, with relevant information experience, or Bachelor's degree in English or communications, with relevant science experience. 
• MS, MPH, PharmD, PhD, or other advanced degree is strongly preferred.
• A minimum of 8 years relevant senior level experience in medical/technical information within the pharmaceutical, biotechnology, or CRO industry and previous line management experience preferred.
• Knowledge of ICH guidance governing drug and document development as well as editorial and publications processes, systems and procedures.
• Track record of successful relationships in building and maintaining relationships with customers, both internal and external.
• Strong management and independent work skills; strong resource planning skills, strong written composition and editorial skills; program planning and implementation skills; and demonstrated copyinformation skills.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

Additional Information
Qualification : B.Sc, MS, MPH, Pharm.D, Ph.D
Experience : 5+ years
Location : Gurgaon
Industry Type : Pharma
Functional Area : Medical Writing
End Date : 25th March, 2019

Project Manager requirement at Syneos health @ Apply Now

Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.

Post : Project Manager II

Job Description
Project Leadership and Delivery:
• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement.
• Lead project team to ensure quality, timelines and budget management.
• Accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.
• Accountable for all project deliverables for each project assigned.

Documentation and Reporting:
• Responsible for quality and completeness of TMF for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct.
• Oversight for development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals.

Business Development:
• Develops strong relationships with current clients to generate new and/or add-on business for the future.
• May participate in bid defense meetings where presented as potential project manager.

Management:
• May be required to line manage other project management team members and clinical monitoring staff

Candidate Profile
• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred.  Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• 10+ years working experience in Clinical Monitoring related roles
• 2+ years of working experience as Clinical Project Experience
• Should have worked for Global / Region operations PM roles
• Working experience on CNS, Ophthalmology TA are preferred 
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

Additional Information
Qualification : B.Pharm, B.Sc
Experience : 2-10+ years
Location : Hyderabad-Madhapur-Village
Industry Type : Pharma
Functional Area : Clinical Project Management
End Date : 30th November, 2018

Require Safety Specialist at Syneos Health

Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.

Post : Safety Specialist I

Job Description
Performs all aspects of the collection, processing, and reporting of adverse events, adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines and study procedures.  May progress to leading minimally complex studies.

1. Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance.
2. Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs) and project specific safety plans.
a) Triages AEs, evaluates AE data for completeness, accuracy, and regulatory reportability.
b) Enters data into safety/adjudication database.
c) Performs Quality Control (QC) of entered data/endpoint dossiers.
d) Codes events, medical history, concomitant medications and tests.
e) Compiles complete narrative summaries.
f)  Discerns what information requires querying and interacts closely with study monitors, investigative site personnel, and sponsor representatives until all follow-up information is obtained and queries are satisfactorily resolved.
g) Participates in generation of reports to the sponsor and regulatory authorities; ensures timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
h) Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases

3. Assists safety project lead/endpoint manager in the preparation of a safety management plan.
4. Distributes all required periodic reports for both clinical and post-marketing  projects.
5. Ensures all aspects of the Company’s safety data collection and processing are consistent with current industry practices and meet all pertinent domestic and international regulatory requirements.
6. Maintains current professional knowledge in fields of safety management, coding, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients.
7. Maintains understanding of  SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
8. Maintains knowledge of ongoing projects and disease-related terminology.

Candidate Profile
• BA/BS in Life Science or Registered Nurse/Pharmacist.  Nominal clinical/clinical research experience or equivalent combination of education and experience. 
• 1-3 years of Safety and Pharmacovigilance case processing experience. 
• Clinical Research Organization (CRO) experience with therapeutic specialties preferred. 
• Knowledge of Argus safety database preferred. 
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet.  Some understanding and usage of medical terminology. 
• Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting. 
• Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy and meet deadlines in a highly dynamic environment. 
• Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment

Additional Information
Qualification : Degree in life sciences
Experience : 1-3 years
Location : Gurgaon-Cyber-City
Industry Type : Pharma
Functional Area : Safety & Pharmaco
End Date : 15th November, 2018