Senior Clinical Trial Specialist
Brookline, Norfolk County, Massachusetts, 02445, USA
Listed on 2026-10-02
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Healthcare
Clinical Research
Senior Clinical Trial Specialist (Contract)
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX
750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.
Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.
Description of RoleThe (contract-to-hire) Sr. Clinical Trial Specialist perform tasks to support the planning and execution of clinical studies across one or more clinical trials. This role is a temporary position with the potential to convert to a permanent rol e, work ing closely with the Clinical Trial Manager (CTM) to ensure site start-up through close-out activities are conducted in accordance with Standard Operating Procedures (SOPs),GCPand regulatory guidelines.
Key Responsibilities- Assist sand provides support to the CTM and study team in the day-to-day operational management of assigned clinical trials.
- Supports the CTM in coordination, preparation, and documentation of internal and external meetings such as Kick-Off Meetings, Investigator Meetings, and vendor management meetings by preparing agendas, minutes, and presentation materials, organizing meeting logistics and travel arrangements if necessary.
- Take responsibility for meeting logistics, agendas, and minutes of the clinical study team in accordance with standards.
- Assist with tracking of purchase orders and invoices, site budgets, investigator payments, CTAs, etc.
- Assists in tracking key site metrics and milestones such as Site Initiation Visits and site activation, subject recruitment and enrollment, critical study dosing days and assessments, scheduled Monitoring Visits and Close-Out Visits etc.
- Contribute to study level tracking by maintaining tools to track assignment and training of study team members, recruitment materials and compliance tools, laboratory kits, samples and study supplies, vendor portal access, etc.
- Support the CTM in the oversight of study vendors; including review of invoices.
- Supports the CTM and contributes to the review of clinical documentation such as Informed Consent (ICF), Study Reference Binder, Study Management Plans, Monitoring plan, study protocols etc.
- Manages and maintains the study team Share Point
- Assists in clinical site oversite, data entry timeliness, review of monitoring trip reports and tracks resolution of all action items.
- Assists in TMF management to ensure it is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
- Assist CTM and study team in the review and cleaning of study data in preparation for database lock.
- B.A. or B.S. degree required.
- 4+ year’s experience within a biotech or pharmaceutical organization.
- Experience working with clinical sites, principal investigators, clinical operations staff and CROs a plus.
- Knowledge and training on Good Clinical Practice (GCP) for clinical research studies.
- Computer skills should include proficiency with Microsoft Office software, specifically, Outlook, Word, and Excel.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent written and verbal communication skills.
- Flexible and able to adapt to new situations as the business demands.
- Ability to work effectively from a virtual home office setting.
- Demonstrates…
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