Senior Clinical Operations Specialist
1 week ago
Discover a new career opportunity at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT.
About Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization. We accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.
We bring the customer and patient to the center of everything we do. Our Clinical Development model simplifies and streamlines work to make us easier to work with and for.
Collaborate with passionate problem solvers who innovate as a team to help customers achieve their goals. We are agile and driven to accelerate therapy delivery because we're passionate about changing lives.
Our 29,000 employees across 110 countries already know that working here matters everywhere.
Why Syneos Health?- We develop our people through career progression, supportive line management, technical training, peer recognition, and total rewards.
- We're committed to our Total Self culture, where you can be authentically yourself. Our culture unites us globally, and we take care of our people.
- We continuously build the company we want to work for and our customers want to work with. When we combine diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
You'll provide operational support to the MCAM Manager and project team members across scoped services.
- Attend committee meetings and prepare meeting materials: agendas, minutes, and action items.
- File all MCAM project documents across all MCAM services to the Trial Master File (TMF).
- Distribute Safety Listings and Expedited Safety Reports for review to Committee Members.
- Review clinical event/endpoint documentation to ensure completeness of adjudication packages, appropriate redaction of Protected Health Information (PHI), and identify potential unreported clinical endpoints or events requiring adjudication.
- Initiate queries to sites as applicable for potential discrepant or missing data and follow to resolution.
- Manage translation services via scope of work, including submission, tracking, and assurance of page equivalent upon return of translation.
- Support User Acceptance Testing (UAT) of Committee's collaborative workspace and/or electronic adjudication platform.
- Provide operational support to the MCAM Manager in creating and maintaining metric reporting for delivery to customers and/or internal teams.
- Other work-related duties as assigned and/or outlined in the Committee Charter.
To succeed in this role, you'll need:
- A BS in life sciences, Medicine, Pharmacy, Nursing, or related field or an equivalent combination of education and experience.
- Prior experience in study coordination, a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred.
- A strong understanding of medical and scientific terminology in multiple environments is preferred.
- Strong organizational and time management skills.
- Excellent communication and interpersonal skills, both written and spoken.
- Knowledge of Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable regulatory requirements.
- High proficiency with full MS Office Applications.
- Ability to travel if necessary, preferably approximately 5%.
- High level of competence in English language.
The annual base salary for this position ranges from $55,800 to $108,600. This figure represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as your qualifications, skills, competencies, and proficiency for the role.
Beyond your salary, you can expect valuable benefits and a quality-of-life balance. These may include a company car or car allowance, health benefits, company match 401(k), eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.
Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.
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Morrisville, United States Lifelancer Full timeAbout Syneos HealthAt Syneos Health, we're dedicated to accelerating customer success. As a leading fully integrated biopharmaceutical solutions organization, we translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.Our CultureWe believe in providing an environment and culture where our people...
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