- Oversee and be the primary point person for all internal and external data management activities
- Work with CROs in designing and updating CRFs, EDC systems and edit checks
- Develop data management documents to support study execution (e.g. Data Management Plans, eCRF completion guidelines, Data Validation Plans, etc)
- Oversee internal and external database cleaning, query resolution and database lock activities
- Support medical with SAE reconciliation and medical coding activities
- Develop data transfer agreements with third parties
- Generate ad hoc data listings and patient profiles to support medical, clinical operations and translational research activities (e.g. listings to support Safety Review Meetings or Dose Escalation Meetings, consolidating translational data sets, etc
- Bachelor's degree required
- 8 -10 years of experience managing data management activities to support oncology clinical studies
- Excellent communication skills and ability to work in a flexible, matrix environment
- Experience managing external resources such as vendors, CROs and consultants
- Advanced working knowledge of all relevant guidelines, including ICH, GCP, and other relevant FDA guidance's
- Excellent oral and written business communication skills
- Ability to drive a team-oriented environment, motivate and influence others, lead strategic discussions and interact with critical internal and external stakeholders
-
Clinical Data Manager
1 week ago
Katalyst Healthcares & Life Sciences Boston, United States**Responsibilities**: · - Lead the design of data collection and management systems and initiate process improvements as needed. · - Establish goals, timelines, and deliverables for data management of Client's trials, and oversee priorities and timelines for all data staff to pro ...
-
Moderna Cambridge, United StatesThe · Ro · l e: · As · th e · S e n · i or · D · i · r e ct or of · D · a · t a · a · n d · S · y · s · t e m s · S · t · r · a · t e g y · a t M od e r · n · a , · y · o u · w · il l · h o l d a · c · r · i · t · i · c · a l · r o l e · i n ...
-
Clinical Data Manager
1 week ago
Katalyst HealthCares & Life Sciences Waltham, United StatesResponsibilities: · Act as primary liaison between Company and CRO for Data Management. · Provide support and oversight for the CRO Data Management team. · Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. · Review cl ...
-
Clinical Data Scientist
2 weeks ago
Icon VendorPass and Affiliates Waltham, MA, United StatesPosition Title: Clinical Data Scientist · Location: Waltham, Ma · Pay Rate: $60/hr (+benefits) · Assignment Length: 1-year W2 Contract · Schedule: Hybrid · Industry: Pharmaceutical · ************* · JOB OVERVIEW · Towards Integrated workflows & Data collection Work han ...
-
Clinical Data Management Study Lead
1 week ago
Ipsen Bioscience, Inc. Cambridge, United States**Clinical Data Management Study Lead**: · **Summary/Purpose of the Position**: · **The Clinical Data Management (CDM) Study Lead defines, implements, and monitors the Data Management strategy for one or more clinical studies in Ipsen portfolio. The Study Lead is responsible for ...
-
Clinical Data Manager
1 week ago
Dragonfly Therapeutics, Inc. Waltham, United StatesClinical Data Manager · Dragonfly Therapeutics seeks a Clinical Data Manager with relevant Clinical Data Management experience to join our Clinical group. This role will report to the Associate Director, Clinical Data Management. This role is responsible for the oversight of all ...
-
Clinical Data Manager
1 week ago
Katalyst HealthCares & Life Sciences Waltham, United StatesResponsibilities: · Act as primary liaison between Company and CRO for Data Management. · Provide support and oversight for the CRO Data Management team. · Collaborate with the team on study design, protocol development, CRF design, statistical planning, and CSRs. · Review cl ...
-
Clinical Data Scientist
4 weeks ago
ICON Consultants, LP Waltham, United StatesHybrid Role · Towards Integrated workflows & Data collection · • Work hands-on with R&B Scientists & technicians in specific sites to upgrade current data operations and practices to build impactful ways of working. · • Work hands-on with R&B users to build automated data workflo ...
-
Clinical Data Manager, Mgh Oos
2 weeks ago
Mass General Brigham Boston, United States**Clinical Data Manager, MGH OOS** · GENERAL SUMMARY/ OVERVIEW STATEMENT: · Receiving direction from the Director of Data Management of the Neurological Clinical Research Institute (NCRI), the incumbent will use a clinical trial data management system for data collection, analysi ...
-
Clinical Data Manager
1 week ago
Dragonfly Therapeutics, Inc. Watertown, United StatesClinical Data Manager · Dragonfly Therapeutics seeks a Clinical Data Manager with relevant Clinical Data Management experience to join our Clinical group. This role will report to the Associate Director, Clinical Data Management. This role is responsible for the oversight of all ...
-
Senior Manager, Clinical Data
1 week ago
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data management activities across our studie ...
-
Manager, Clinical Data Management
3 weeks ago
Deciphera Pharmaceuticals Waltham, MA, United StatesCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in ...
-
Manager, Clinical Data Management
1 week ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...
-
Senior Manager, Clinical Data
1 week ago
TScan Therapeutics Waltham, United StatesPosition Summary: · TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data management activities across our studi ...
-
Manager, Clinical Data Management
1 week ago
Deciphera Waltham, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
-
Manager, Clinical Data Management
1 week ago
Deciphera Pharmaceuticals Waltham, United StatesCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...
-
Senior Manager, Clinical Data
1 week ago
Tscanrx Waltham, United StatesTScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data management activities across our studies in solid tumors an ...
-
Clinical Research Data Specialist-cancer Center
3 weeks ago
Massachusetts General Hospital(MGH) Boston, United States**Clinical Research Data Specialist-Cancer Center Protocol Office** · **GENERAL SUMMARY/ OVERVIEW STATEMENT**: · The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS). The Cancer Center P ...
-
Manager Clinical Data Management
1 week ago
Deciphera Pharmaceuticals Waltham, United StatesJob Description · We are seeking a Manager to Lead Clinical Data Management (CDM) activities for clinical studies or a clinical program. This position will report to the Associate Director/Director of CDM and work on-site at our Waltham, MA office. Deciphera embraces a flexible ...
-
Manager, Clinical Data Management
1 week ago
Deciphera Pharmaceuticals Waltham, United StatesDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to d ...
Senior Manager, Clinical Data - Waltham, United States - TScan Therapeutics
Description
Job Description
Job DescriptionPosition Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Senior Clinical Data Manager to oversee data management activities across our studies in solid tumors and hematological tumors. The ideal candidate should have relevant experience in oncology clinical studies and enjoy a fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
Requirements:
About TScan:
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.