About The Position

Global Project 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 (5) years of relevant experience as Global CTM
  • Clinical research organization (CRO) and ONCOLOGY therapeutic experience preferred.
  • Early phases preferred.
  • 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%).

Responsibilities

  • Direct liaison with CROs and other vendors to manage relevant trial(s) operational tasks.
  • assists in the review, development and writing of clinical trial documents and manuals and other supporting documents.
  • create Master ICF template and review/approve sites changes
  • participate in the feasibility and evaluation of investigative sites
  • coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization.
  • assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan.
  • plan and organize meetings with team support
  • assist in the development of the IP and co-medication strategy
  • participate in data review and discrepancy resolutions.
  • participate in coordinating efforts with internal pharmacovigilance and safety group.
  • monitor study-specific timeslines and key deliverables; focus on management of all external vendors
  • participate as a member of the multi-disciplinary trial team.
  • develop relationships with investigational sites and institutions to enhance conduct of the trial.
  • acts as preliminary liaison for study sites to convey trial information

Benefits

  • 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.
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