- Bachelor's degree in life sciences or healthcare related field, or relevant employment experience
- 3+ years of experience working in the pharmaceutical/biotech industry
- Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files
- Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visits reports, study and vendor related KPIs etc.
- Maintain and ensure all documentation is in a state of audit readiness
- Support CTM and SMT in maintaining appropriate training records according to training matrix
- Responsible for organizing and maintaining clinical operation SharePoint folders documents are easily available
- Maintenance of the Trial Master File and/or electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs
- Assist in the preparation of study related documents, i.e., ICF, study plans and manuals, training documentation, SMT slides etc.
- Support drug supply planning and defining supply logistics
- Coordinate and track clinical trial equipment and supplies
- Work with the Clinical Trial Manager (CTM) to review and track vendor invoices against contracts and coordinate approval. Track contracts from draft to executed, including CDA/NDA, SOW and MSA
- Assist with site budget process
- Support the trial team to produce and distribute study newsletters
- Create agendas and record team meeting minutes under the direction of the CTM
- Participate in CTA meetings and lead implementation of process improvement initiatives including but not limited to the development of trial and vendor related KPIs, document tracking tools, dashboards and templates
- Assist the CTM/study lead with timeline maintenance
- Responsible for administrative management of the SMT meetings and additional meetings including preparation of agenda and minutes
- Support preparation for and participate in investigator meetings (face to face or virtual) as required
- Assist with relevant administrative tasks relating to the wider operations function, such as clinical supplies, data management, TMF or patient recruitment, if assigned
- Assist and participate in quality related initiatives and activities including SOP and other controlled document preparation and inspection readiness activities
- Support the head of clinical operations or team members on the onboarding of new starters
- Provide administrative assistance to the clinical team as needed, such as booking meetings and conference rooms, assisting with expense as requested, other administrative assistance as needed
- Solid understanding of the responsibilities and needs of the various functions in a clinical trial
- Strong computer skills including knowledge of MS Excel, Word, PowerPoint, and Outlook
- Proven ability to work independently, and effectively handle multiple priorities in a fast-paced environment
- Ability to maintain confidentiality of proprietary information expected
- A team player that takes the initiative when appropriate but seeks guidance when needed
- Excellent interpersonal skills, strong organizational skills, and effective communication within an organization
- Proficient written and verbal communication skills
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Clinical Trial Associate - Lexington, United States - Wave Life Sciences
Description
Job DescriptionWave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a preclinical program in obesity. Driven by the calling to "Reimagine Possible", we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description:
The Clinical Trial Associate (CTA) supports the Clinical Operations, Supply and Data Management department in the planning, execution, and management of clinical trials. The CTA will review, track and file study specific documents as well as create and update study specific reports. They may be required to undertake tasks on a given study, across several studies and/or provide administrative support across the department. They must exercise discretion and judgment in handling confidential information and will follow, ICH guidelines and GCP in all tasks as well as adhere to global regulatory requirements as required. Strong organizational skills are required, as well as the ability to balance changing priorities.
Experience:
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.
