- Function as a Clinical Data Manager (CDM) to coordinate the day-to-day support of CDM results from study start-up through to database lock to receipt of final study outputs for clinical studies outsourced to contract research organizations.
- Work collaboratively with project study teams comprised of internal staff and external vendors for multiple global projects assigned to the post holder. Lead timelines of CDM results or assigned projects, ensuring the internal project team is up to date on these activities.
- Ensure that clinical or other relevant human research studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable regulations/guidance, global/internal data standards (CDISC) and company Standard Operating Procedures.
- Give to or assist in development of request for proposal (RFP) for CDM needs, where needed including Electronic Data Capture (EDC) platforms, budget implications, overall governance of CDM processes and outsourcing.
- Provide expertise in design and delivery of internal eCRF specifications according to protocol and approved standards for assigned clinical studies; coordinate development of new standards as needs permit.
- The CDM role will take direction from the clinical operational unit, including undertaking any other tasks allocated to them within the CDM domain following discussion.
- 1 to 3 years of direct experience of data management activities in clinical studies and competent level of understanding clinical research processes and clinical data management lifecycle.
- Ability to drive cross-functional collaborative efforts with multiple collaborators, internal clinical research partners and outsourced vendors.
- Capacity to work and make decisions with minimal supervision.
- Excellent time management and team collaboration skills.
- Excellent oral and written communication skills.
- Proficiency and ability to apply and document quality and regulatory practices / procedures supporting research studies.
- Ability to creatively supply to key strategies at the department/division/enterprise level
- PhD, Master's, or Bachelor's degree required in biology, chemistry, clinical science, pharmacy, public health, toxicology, or a related field.
- Global Top Employer with 53,000 British American Tobacco employees across more than 180 markets
- Great Place to Work Certified
- Brands sold in over 200 markets, made in 44 factories in 42 countries
- Newly established Tech Hubs building world-class capabilities for innovation in four strategic locations
- Diversity leader in the Financial Times and International Women's Day Best Practice winner
- Seal Award winner - one of 50 most sustainable companies
- 401(k) plan that offers opportunity to save on pre- and post-tax basis up to 50 percent of eligible compensation.
- Company matches 100 percent of employee pre-tax/Roth (401k) contributions up to six percent
- Company contributes an additional three percent to 401(k) whether employee participates or not
- Comprehensive health- and welfare-benefits package (including medical, dental, vision, and prescription drugs)
- Health Savings Account start-up contribution for employees who elect the high deductible health plan
- Flexible spending accounts for both Health Care and Dependent Care allowing employee to use pre-tax dollars to pay for qualified expenses during the calendar year
- Employee assistance program offering 8 free counselling sessions, per issue, each calendar year for employees and their dependents
- Company paid life insurance of 1x annual base pay ($50,000 minimum)
- Company paid accidental death or dismemberment insurance of 2x annual base pay ($50,000 minimum)
- Voluntary insurances offered at group rates: employee and dependent life insurance, AD&D insurance, critical illness, accident coverage, disability buy-up, and auto & home insurance
- Tuition reimbursement and student loan support
- Dependent Scholarship Programs
- Free confidential personal financial counselling service
- On-site health centers and 24/7 fitness centers at certain company locations
- A charitable giving matching grants program that enables employees to direct and double their donations to qualifying charitable organizations of their choice
- Health-care concierge service
- Volunteer service opportunities
- Extensive training opportunities
- Company vehicle for eligible employees
- Mobile phone allowance for eligible employees
- Paid Leave:
- Sick and Personal Time (exempt employees may be excused with pay for brief absences; non-exempt employees receive up to 6 days)
- Vacation (levels Below Senior Director receive 15 days (pro-rated during first year of service); Senior Director and Officers receive 25 days (pro-rated during first year of service)).
- Holidays (Nine company recognized and two annual personal holidays to be used at the employee's discretion)
- Paid Parental Leave + temporary reduced work schedule opportunity
- Funeral Leave
- Short-Term Disability Leave
- Long-Term Disability Leave
- Jury Duty Leave
- Military Leave
- Released Time for Children's Education
- Community Outreach Leave
- Other paid leave benefits, as required by state or local law
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Sr Scientist Clinical Data Manager - Winston Salem, United States - British American Tobacco
Description
Reynolds American is evolving at a pace like no other organization.
To achieve the ambition we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day.
WE ARE LOOKING FOR A SR SCIENTIST CLINICAL DATA MANAGER
SENIORITY LEVEL:
Junior Management Level
FUNCTION:
Scientific Research & Development
LOCATION:
Winston Salem, NC
ROLE POSITIONING AND OBJECTIVES
Reports to
Director Clinical Studies
Number of Direct Reports
0
Core Relationships
Internal - Clinical Studies, Scientific & Regulatory Affairs, Product Development
Geographic Scope
Local
Travel Required
Less than 10%
WHAT YOU WILL BE ACCOUNTABLE FOR
At Reynolds American, we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at REYNOLDS AMERICAN.
Have you been on a career break for 18 months or longer? Are you ready to return to your career? If your answers to these questions is yes, we would love to hear from you.
Regardless of why you took a break, we value you for all the skills you can bring to the workforce.
Reignite your career, work flexibly, be part of a dynamic team and upskill yourself with on-the-job training and development support.
Collaboration, diversity and teamwork underpin everything we do here at Reynolds American.We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals.
Come bring your differenceSALARY AND BENEFITS OVERVIEW
Benefit Information
The following is a general summary of the competitive compensation and benefit plans we offer:
Reynolds American its affiliated companies is an Equal Opportunity/ Affirmative Action Employer.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by applicable law.
Only applicants requiring reasonable accommodation for any part of the application and hiring process should contact us directly via email at
