- Support the clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.
- Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
- Work closely with external collaboration partners with a focus on relationship management and efficiency
- Lead the proactive identification, assessment, and management of clinical study challenges and risks.
- Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.
- Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
- Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
- Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.
- Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study.
- Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.
- Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
- Contribute to and/or author clinical sections of regulatory documents including Investigators' Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.
- Bachelor's Degree is required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Minimum of 2-5 years clinical trial management experience in the pharmaceutical, biotech and/or CRO industry.
- Experience in Oncology Studies and/or Phase 3 trials preferred.
- Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
- Knowledge of global clinical trial management in fast paced CRO outsourced environment. Ability to assemble a plan and execute on the details.
- Experience and ability to manage global or regional teams in a virtual environment.
- Experience with Phase 2 to Phase 3 studies preferred.
- Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
- Must be adaptable and enjoy working in a fast-paced environment.
- Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables.
- Willingness to travel up to 10-20% of the time.
-
Clinical Trial Manager
1 week ago
Green Key Resources Boston, United StatesWe are seeking a dedicated Clinical Trials Manager to oversee all aspects of clinical trials, ensuring adherence to timelines, budgets, and quality standards. The incumbent will facilitate collaboration across functional areas and manage relationships with external partners to en ...
-
Clinical Trial Manager
2 weeks ago
EPM Scientific Boston, United StatesClinical Trial Manager · Salary: $150,000-$165,000 · This biotech is leading company focused on developing innovative therapies for rare diseases. Their mission is to bring life-changing treatments to patients who have few or no options. They are a dynamic and fast-growing compa ...
-
Clinical Trial Manager
3 hours ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Clinical Trial Manager
3 weeks ago
Clinical Dynamix Boston, United StatesResponsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I‐IV of development. · RESPONSIBILITIES · Clinical Operations team member: works closely with the Sr. CTM and/or Director of Clinical Operations and is r ...
-
Clinical Trial Manager
3 weeks ago
Work In Biotech Boston, United StatesAbout us: Ascidian is redefining the treatment of disease by rewriting RNA. Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow from larv ...
-
Senior Clinical Trial Manager
4 weeks ago
EPM Scientific Boston, United StatesSenior Clinical Trial Manager (Hybrid in Boston, MA) · Salary: $160,000-$185,000 · A dynamic and rapidly growing biotech in the heart of Boston, Massachusetts is seeking a highly skilled and motivated Senior Clinical Trial Manager to lead and drive the successful execution of the ...
-
Sr. Clinical Trial Manager
8 hours ago
Proclinical Staffing Boston, United StatesProclinical is seeking a dedicated Senior Clinical Trial Manager (CTM) to join our global Clinical Operations Department. The successful candidate will play a crucial role in managing and executing clinical trials, ensuring compliance with regulations, maintaining timelines, and ...
-
Senior Clinical Trial Manager
2 weeks ago
Argenx SE Boston, United StatesPURPOSE OF THE FUNCTION · The Senior Clinical Trial Manager (CTM) is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase ...
-
Clinical Trial Manager
3 weeks ago
Ascidian Therapeutics Boston, United StatesAbout us: · Ascidian is redefining the treatment of disease by rewriting RNA. · Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who are primordial ancestors of vertebrates. To grow fro ...
-
Clinical Trial Manager
2 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiov ...
-
Clinical Trial Manager
3 weeks ago
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiova ...
-
Fusion Pharmaceuticals LLC Boston, United StatesFusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting ...
-
Clinical Trials Manager
3 weeks ago
Tufts Medicine Boston, United StatesWe're saving lives, building careers, and reimagining healthcare. We can't wait to grow alongside you. · Job Profile · Summary · This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In ad ...
-
Clinical Trial Manager
2 weeks ago
Clinical Dynamix Boston, United StatesResponsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I‐IV of development. · Please ensure you read the below overview and requirements for this employment opportunity completely. · RESPONSIBILITIES · Cli ...
-
Senior Manager, Clinical Trial Lead
2 weeks ago
Olema Pharmaceuticals Boston, United StatesAbout the Role >>> Senior Manager, Clinical Trial Lead · We are looking for a Senior Manager, Clinical Trial Lead (CTL) for our growing Clinical Operations team. The Senior Manager, Clinical Trial Lead is responsible for the day-to-day management of clinical trials, vendors, and ...
-
Senior Manager, Clinical Trial Lead
2 weeks ago
Olema Oncology Boston, United StatesWho We Are >>> Why You Should Work With Us · Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietar ...
-
Clinical Trial Project Manager II
19 hours ago
Massachusetts General Hospital Boston, United StatesClinical Trial Project Manager II - Neurological Clinical Research Institute · The Neurological Clinical Research Institute (NCRI), at the Massachusetts General Hospital (MGH) is a premier Academic Clinical Research Organization (CRO) managing clinical trials in neurological dis ...
-
Contract Clinical Trials Manager
3 weeks ago
Clinical Dynamix Boston, United StatesClinical Phase Publicly Traded Biopharmaceutical company focusing in pulmonary delivered therapies · Job Summary: CTM work from home 3 days a week and in-office in Tuesdays and Thursday (flexible hours) 40 hour/week Contract to begin with option to convert to perm/Full time · Th ...
-
Senior Manager, Clinical Trial Lead
3 weeks ago
Olema Oncology Boston, United StatesWho We Are >>> Why You Should Work With Us · Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprieta ...
-
Clin Trial Asst Proj Manager
6 days ago
Massachusetts General Hospital Boston, United StatesClin Trial Asst Proj Manager · The Massachusetts General Hospital Stroke and Neurocritical Care Research Center is one of the largest and most prolific stroke research centers in the country employing a diverse team of clinical researchers managing novel clinical trials in stroke ...
Associate Director Clinical Trial Management - Boston, United States - Bicara Therapeutics
4 weeks ago
Description
Role Overview
The Associate Director - Clinical Trial Management works within the clinical trial team to provide regional trial oversight and ensures deliverables are met in terms of quality, compliance, and timing. Strong vendor management is critical for this role. The position will report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities.
Key Responsibilities
Clinical Operations
Qualifications
Company Overview
Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company's bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara's lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara's experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at
Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.
Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
