Global Clinical Trial Manager. Anywhere in the USA. FSP

Syneos Health

17h

About The Position

Global Clinical Trial Manager. Anywhere in the USA. FSP 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 29,000 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.

Requirements

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience and at least (3) years of relevant experience as Global CTM
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

Nice To Haves

• Clinical research organization (CRO) and ONCOLOGY therapeutic experience preferred.
• Early phases preferred.

Responsibilities

• STUDY OVERSIGHT Request and ensure delivery of Pharmacovigilance database set-up, training slides, and SAE forms
• Develop Master Informed Consent Form(s) and management of all template updates
• Country and Site specific ICF Review
• Maintain updated Trial Master File (TMF)
• Maintenance of Study Logs as appropriate
• Project Planning Develop/Review Study Plans, Manuals and tools, as applicable
• Manage Vendor specification development/review.
• Review of monitoring reports
• Site Management User Management Tool (UMT) oversight and report review
• Site visits, as required (i.e. site engagement, etc.)
• Draft and ensure review and approval of study newsletters and other correspondence prior to approval for release.
• Help follow up with sites for data entry and query resolution, as needed.
• IP Management Facilitate label development and translations
• Develop/Review IP distribution and returns protocol for drug depot
• Answer site IP questions and coordinate with IRT
• Actively manage the IP inventory at the depot
• Work with sites/Monitors to ensure Return or Destruction of IP and trial materials
• Vendor Management Investigator Meeting(s) / Vendor management (day-to-day interactions)
• Help ensure Vendor equipment return

Benefits

• We reward and recognize our people by providing valuable benefits and a quality-of-life balance.
• The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, 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.
• Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work.
• Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level