Senior Clinical Trial Associate (Sr. CTA)
MapLight TherapeuticsBurlington, Massachusetts, United States · Posted 3 months agoDescription
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do:
The Senior Clinical Trial Associate (Sr. CTA) is required to help support Clinical Operations and project teams. The position offers much responsibility and the opportunity to be involved in all phases of the clinical project. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to their end.
Responsibilities:
- Interact directly with Clinical (e.g., CRAs, trial managers), site staff, vendors (U.S. and worldwide, as necessary), to provide support in project-specific tasks and the overall management of clinical trials
- Directly support under the guidance of Operational Leaders, Clinical Leaders, and Clinical Trial Managers. Specific responsibilities include:
- Maintain and manage requests for access to and deactivation of study systems users.
- Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings, including requests for materials from external consultants, suppliers, etc.
- Distribute safety alerts and relevant documents, if required
- Maintain and update study team and vendor contact information
- Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates
- May participate in reviewing, formatting and finalizing study-related templates, plans and manuals
- Assist with maintaining clinical trial insurance
- Assist with questions, issues or requests from the Clinical Research Organization (CRO)/study team and route to the appropriate individual within the organization for resolution
- May participate in clinical data review, as required
- Responsible for the completeness of documents managed in the Trial Master Files (TMF); performs ongoing reviews of TMF to assure quality of the documentation files and compliance with SOPs and ICH GCP Guidelines
- Route, track and file Clinical documents. May conduct initial/ongoing review of site Clinical regulatory documentation to confirm completeness/track dates and distribute to appropriate team members for review
- Develop and maintain study-related trackers that will support Clinical Operations and individual studies. May analyze or update data associated with the trackers
- Other duties as assigned to support Study Team Leads and Operational Team Leads
Qualifications:
- Bachelor’s degree in a relevant subject area is highly recommended or a combination of education and applicable job experience may be considered.
- Minimum 2+ years in the biotech /pharmaceutical industry /clinical trial management area
- Competency of the drug development process with knowledge of ICH-GCP is a plus
- Strong interpersonal, organizational and planning skills along with excellent verbal and written communication skills
- Proactive and self-starter with the ability to take responsibility for tasks and execute seamlessly. Be able to identify areas for efficiency across studies in the spaces that the position is responsible for.
Travel:
- Ability to travel up to 35%
Location: 3 day hybrid in office in Burlington, MA
MapLight does not accept unsolicited resumes from recruiters, staffing agencies, or search firms.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Similar jobs
Est. 220,000 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 142,500 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 298,500 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 210,000 USD
Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology,…
Est. 141,000 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Est. 85,000 USD
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy throug…
Est. 170,450 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 120,000 USD
Isomorphic Labs is applying frontier AI to help unlock deeper scientific insights, faster breakthroughs, and life-changing medicines with an ambition to solve all disease. The future is coming. A future enabled and enric…
Est. 160,000 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 70,000 USD
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA…
Est. 127,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 185,600 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 172,250 USD
About Beeline Medicines: Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and i…
Est. 161,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 187,500 USD
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on…
Est. 127,000 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 159,500 USD
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments…
Est. 120,000 USD
At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support serv…
Est. 266,000 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have th…
Est. 67,440 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 125,000 USD
Join Us in Shaping the Future of Clinical Research Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromisi…
Est. 160,000 USD
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with…
Est. 181,500 USD
Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitmen…
Est. 143,750 USD
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases.…
Est. 191,000 USD
About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatme…
Est. 120,000 USD
Syndax Pharmaceuticals is looking for a Contractor, Clinical Trial Manager At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a…
Est. 189,500 USD
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Sum…
Est. 266,000 USD
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team…
Est. 109,000 USD
Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity The TMF Operations Lead plays a critical role in ensuring our clinical trial documentat…