Clinical Trial Associate - #257452

Your Experience Includes…

• Bachelor’s or advanced degree in a relevant scientific or healthcare discipline
• Two or more years of prior experience working in healthcare, pharma or biotech required; prior clinical trial experience is a plus
• Knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives.
• Strong organizational skills, with ability to manage multiple tasks and prioritize workload effectively
• Excellent written and oral communication skills with the ability to effectively interact with study team members and internal and external stakeholders
• Ability to thrive in a fast-paced environment with a demonstrated ability to prioritize and manage
• Ability to work independently as well as collaboratively in a team-oriented environment
• Proficiency in Microsoft Office Suite, including Project, PowerPoint, Word and Excel, and SmartSheets
  
  

You are interested in…

• Assisting the Clinical Operations team members with project-specific support related to the conduct of clinical trials activities
• Supporting the Clinical Trial Manager/Clinical Operations Lead in clinical study documentation preparation, tracking and maintenance
• Maintaining trial master files (TMFs) and study documentation in accordance with regulatory requirements and internal SOPs.
• Developing and maintaining study-related trackers to support Clinical Operations
• Assisting in planning and organizing internal and external study-specific meetings, including preparation and distribution of meeting materials, agendas and minutes
• Assisting in the coordination and tracking of clinical supply shipments, equipment, and study-specific laboratory samples
• Tracking study and program metrics
• Maintaining and updating the study team list, including vendor contact information
• Reviewing and maintaining study specific training documentation
• Reviewing and updating system access user lists in accordance with processes and study specific plans
• Participating in reviewing, formatting, and finalizing study-related templates, logs, plans, and manuals
• Supporting the monitoring and tracking of study progress, including site start-up, patient recruitment and enrollment, to ensure adherence to study timelines and milestones
• This opportunity may support financial tasks for the study such as budget tracking and accruals
• Performing additional tasks as requested
  
  

About you:

You are an individual with excellent organizational skills, who will provide Clinical Operations team members with project-specific support related to the conduct of clinical trials activities and ensure effective and efficient conduct of clinical research studies by providing administrative and project tracking support

Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence.

Meet your Manager:

All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening.

Navreet Dhindsa – Senior Vice President, Clinical Operations

Navreet is a Dentist by training and has over 23 years of drug development experience in the Pharmaceutical and Biotechnology industry. She has successfully held progressive Clinical Operations leadership roles within diverse settings, including big Pharma, we well as mid-size to early-stage Biotech organizations. Most recently, Navreet was Head of Global Clinical Operations at Apellis Pharmaceuticals, where she provided strategic leadership and oversight of Clinical Operations, Business Optimization and TMF functions.

Meet our Leadership Team and Board of Directors

Meet your Talent Partner:

Narissa Furtado-Cordeiro - Manager, Talent Acquisition 

Narissa joined the Biotechnology industry shortly after graduating with her BS in Marketing from Franklin Pierce University. She is currently pursuing an MS in Legal Studies from Northeastern University School of Law while working full time as a Manager in Talent Acquisition at Tessera. She is passionate about helping individuals find a fulfilling opportunity while considering their interests, aspirations and technical skills. Narissa lives in Northern Vermont and enjoys spending time outdoors with her husband, three-year-old daughter and German Shepherd.

Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits currently include group medical, vision and dental coverage, group life and disability insurance, 401(k) with company contribution, tuition reimbursement, and much more.

Company Summary:

Tessera Therapeutics is pioneering Gene Writing— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability.

More about Tessera Therapeutics:

Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or [email protected]

Recruitment & Staffing Agencies: Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto.