Careers at LumaBridge

LumaBridge is an oncology-focused clinical contract research organization (CRO). For us, science and patient well-being are the central mission.

We are looking for talented individuals who share our vision of helping advance the development of new therapeutics in the fight against cancer. If that’s you, please consider our available positions and apply below to join our team.

Current Openings

All roles are remote and full-time unless otherwise indicated. Some roles may require travel.

The Director, Clinical Operations is a management level team member responsible for contributing to the oversight and management of the Clinical Operations Department at LumaBridge. This position is integral in the development and communication of strategies and resources that foster the successful execution of client projects and deliverables.

Reports To:

Vice-President, Clinical Operations

Location:

This is a remote-based position.

Responsibilities:

The Director, Clinical Operations is a leader who is highly organized and results-oriented with excellent verbal and written communication and interpersonal skills. He/she possesses the ability to recognize and adapt to a change in scope of work while proactively presenting solutions. This position is accountable to the clinical department head and executive team. Essential duties and responsibilities include but are not limited to:

Directly supervise and serve as primary point of escalation for assigned clinical staff.
Provide strategic oversight over clinical project teams that guide timelines, budgets, resources, contractors/vendors, and the applicable needs of a project and/or client.
Work with department staff to project clinical project staffing levels and assignments based on availability and current/future client needs.
Ensure assigned clinical department staff have the knowledge, skills, resources, and training needed to support the project objectives and deliverables.
Proactively collaborate with Finance and Business Development to ensure the accuracy of assumptions built into proposals and clinical study budgets and revisions.
Partner with Business Development colleagues to participate in proposal development and bid defense activities.
Provide guidance to assigned staff with regard to monitoring for potential overburns.
Ensuring assigned clinical staff compliance with time tracking requirements as per business needs.
Proactively evaluate and manage assigned clinical staff performance and address issues in collaboration with Human Resources.
Monitor status reports for clinical projects and provide regular updates to the executive team as indicated.
Partner with the Quality Assurance department to develop, implement, and continuously reevaluate Clinical Standard Operating Procedures (SOP) and training in collaboration with other clinical department leadership.
Liaise with the Quality Assurance department to remedy any inspection findings by Sponsors or regulatory bodies.
Facilitate clinical department compliance with company SOPs.
Partner with Human Resources to recruit employees to ensure clinical department is staffed with qualified personnel, and assist with employee coaching and/or terminations as needed.
Represent clinical department leadership on Sponsor calls when needed.
Participate in bid defense activities in the procurement of new business as needed.
Attend client meetings and teleconferences periodically and when needed.
May serve as CPM/CTM on assigned projects as needed or provide coverage to projects with CPMs/CTMs on leave.
Chair group meetings in support of clinical development and training.
Other duties as assigned.

Qualifications:

Bachelor's degree in health care or other scientific discipline or educational equivalent. Advanced degree (Masters or above) preferred or equivalent combination of education/experience.
Minimum 10 years clinical research and trial experience in the biopharmaceutical industry or at a contract research organization (CRO).
Minimum 5 years of experience in direct management and/or supervising clinical teams.
Knowledge of industry standards, such as ICH guidelines, CFRs, and FDA guidelines.
Strong proficiency in Microsoft applications such as Excel, Word, and PowerPoint.
Strong understanding of clinical trial processes and systems. (EDC, IWRS, CTMS, etc.)
Excellent verbal and written communication, organizational and interpersonal skills.
A high degree of flexibility and ability to adapt to changing landscape of clinical research execution.

APPLY NOW

We are currently seeking an experienced Clinical Project Manager (CPM). The CPM is overall accountable for the leadership and oversight of assigned studies ensuring compliance with GCP, quality, adherence to timelines and budget management. The CPM will perform key job functions in accordance with FDA regulations, ICH GCP, LumaBridge SOPs and study protocols, while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. The CPM is the primary point of contact for internal and external (Sponsor) communications regarding the study.

Location:

This is a remote-based position.

Responsibilities:

Collaborate with the clinical team and other departments as needed to meet deliverables of the assigned project. Regularly communicate with the project team and lead project team meetings to ensure that timelines, resources, interactions, and quality are consistently maintained.
Effectively communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues via mass communication and study newsletters.
Lead and/or participate in meetings and conference calls with Sponsors, vendors and executive management.
Prepare clinical study documents and review or contribute to other functional operational plans.
Prepare study timelines according to project specifications and internal feasibility; monitor compliance to expected timelines throughout the study and escalate potential shippage/delays to Director, Clinical Operations.
Train contract CRAs, LumaBridge staff, vendors, and ensure that investigators and study coordinators are trained on study requirements.
Initiate and oversee project-specific training matrix to document key training throughout the study.
May oversee feasibility and site activation process for each study along with TMF setup; Manage clinical supplies logistics.
May review site Informed Consent forms and site related materials as needed. • Authorize site activation and IP shipments.
May manage patient enrollment, including projections of IP usage and IP inventory management.
Assist CDM staff in the design and development of CRFs, CRF completion guidelines, and UAT as required.
Ensure provision of monthly reports to the Sponsor for active projects as required.
May review and approve monitoring visit reports.
Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
Monitor metrics to evaluate the CRA and site performance.
Maintain a risk management tool to proactively identify, communicate and mitigate project risks throughout the study.
Coordinate protocol deviation review meetings to identify trends and recommend corrective actions as needed.
Ensure inspection readiness at all times of TMF.
Perform and oversee the TMF QC of assigned study(ies), as applicable.
Manage LumaBridge contracted vendors for on-time delivery and compliance with scope of work.
Review investigator payments for accuracy and ensure effectiveness of site budget/contract process.
Review and approve all vendor and site pass-through invoices in accordance with executed contract.
Maintains detailed knowledge of study resource requirements, burn rates and plans accordingly, ensures timelines, quality standards and budget expectations are met. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration.
Complete monthly unit billing grids and monitor available remaining units as applicable.
Understand the project scope of work and identify out-of-scope activities which may necessitate a change order.
RFP / Bid defense preparation and presentation.
Audit preparation and follow-up.
Facilitate data cleaning activities with CRA and CDM staff.
Ensure appropriate record retention per ICH guidance and delivery of TMF and final locked database to client at study close out.
Partner with QA to provide responses to findings resulting from regulatory or Sponsor inspections.
Ensure adherence to FDA regulations, ICH GCP, LumaBridge SOPs and study protocols.
Perform line management duties of direct reports including CRAs and CTAs as applicable.
Provide project status updates to AD or Director, Clinical Operations and/or executive team and escalate issues in a timely manner.
Other duties as assigned.

Qualifications:

Bachelor’s degree in life science/biomedical/medical science with a working knowledge of the clinical/scientific terminology and methods common to the biopharmaceutical setting.
2+ years of monitoring experience preferred.
2+ years of prior full-service project management experience at a CRO or Sponsor.
3+ years oncology experience required; phase I oncology experience preferred.
Demonstrated leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
Excellent planning and organizational skills to enable effective prioritization of workload.
Capable of working effectively in a changing environment with complex/ambiguous situations.
Strong communication (written and verbal) and interpersonal skills.
Fluent in English (written and verbal).
Extensive understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines).
Proficient computer skills to effectively use automated systems and computerized applications such as Electronic Data Capture, CTMS, Outlook, Excel, Word.
Proficient in development of documents and plans with limited oversight.
Ability to cover site visits (PSV, SIV, IMV, COV) for a CRA as needed.
Proficiency with Gantt charts or other timeline software a plus.
Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
Ability to independently prioritize tasks with excellent time management skills.
Extensive knowledge of clinical research processes.
Excellent organizational and leadership skills.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within various clinical trials, and quickly adapt to changes in priorities.
Ability to reason independently and recommend specific solutions to clinical operations issues.
Understanding of basic data processing functions, including electronic data capture and activities required for interim analysis and database lock.
Proficient knowledge of current ICH GCP guidelines and applicable regulations.
Ability and willingness to mentor CRAs and CTAs.
Strong attention to detail.
Ability and willingness to travel as required (<15%)

APPLY NOW

We are currently seeking an experienced Clinical Trial Manager (CTM). The CTM will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, LumaBridge SOPs and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. The CTM leads the clinical operations team to ensure successful delivery of clinical studies in accordance with protocol and budget. Ensures optimal productivity and quality to drive Sponsor satisfaction and strong financial performance. Proactively identifies, resolves/mitigates and escalates risks and/or issues.

Location:

This is a remote-based position.

Responsibilities:

Author the Clinical Monitoring Plan to manage and prioritize the clinical deliverables (e.g., site recruitment, site selection, subject recruitment, data monitoring) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and Sponsor expectations.
Maintain thorough knowledge of contract details. Escalate out-of-scope task requests for review and approval prior to execution.
Review metrics and other information sources to monitor clinical team performance.
Oversee TMF, clinical trial management system (or other applicable system) setup and maintenance, including but not limited to site startup tracking, protocol deviations, clinical/study risks, patient status tracking, FAQs, monitoring visits details, etc.
- Oversee feasibility and site activation process for each study along with TMF setup.
- Manage clinical supplies logistics.
- Review master Informed Consent Forms (ICFs), site ICFs and site related materials as needed.
- Authorize IP shipments.
- Manage patient enrollment, including projections of IP usage and IP inventory management.
- Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
Review and approve CRA monitoring visit reports.
Collaborate with a cross-functional group of clinical operations, clinical data management, and biometry team members to achieve successful delivery of data to Sponsor. Ensure timely data entry, query resolution, and data review, to ensure quality data deliverables.
Serve as the primary liaison for clinical monitoring, site risks, and issues; recognize potential risks within the study protocol and operational aspects of the trial; proactively establish contingency and mitigation plans.
Analyze metrics and reports to keep abreast of study performance.
Ensure that quality standards and applicable regulatory requirements are met.
Oversee filing of study and site level essential documents by project team members to ensure documents are managed in accordance with the TMF Plan; participate in site and study-level TMF QC per TMF Plan.
Communicate effectively with Sponsor, Vendors, CPM, functional team leads, and other project team members; select appropriate communication platforms to convey information effectively and efficiently.
Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
Lead clinical study team meetings.
Present at intra-/interdepartmental and external meetings.
Create and maintain applicable project documents, plans, templates, and tools.
Participate in audit preparations and follow up, as needed.
Other duties as assigned.

Qualifications:

Bachelor’s degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.
3+ years of oncology experience required; phase I oncology experience preferred.
2+ years of monitoring experience preferred.
2+ years of prior CTM experience at a CRO or Sponsor preferred.
Thorough knowledge of clinical research processes.
Strong communication (verbal and written) and interpersonal skills.
Excellent organizational and leadership skills.
Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
Ability to manage multiple priorities within various clinical trials, and quickly adapt to changes in priorities.
Ability to reason independently and recommend specific solutions to clinical operations issues.
Understanding of basic data processing functions, including electronic data capture and activities required for interim analysis and database lock.
Proficient knowledge of current ICH GCP guidelines and applicable regulations.
Ability and willingness to mentor CRAs and CTAs.
Ability to independently prioritize tasks with excellent time management skills.
Highly proficient in computer applications including Microsoft suite of applications, EDC and CTMS applications.
Strong attention to detail.
Fluency in English (written and verbal).
Ability and willingness to travel as required (<15%).

APPLY NOW

We are currently seeking an experienced Clinical Research Associate (CRA). The CRA will be the primary liaison between the Investigator sites and LumaBridge, responsible for overall site conduct and establishing important relationships with key site personnel. The CRA will perform key job functions in accordance with ICH Good Clinical Practice (ICH GCP), FDA regulations, LumaBridge SOPs, and work practices while supporting the organizational mission to advance the development of promising oncology therapies and technologies to benefit patients. CRAs are expected to work in a hands-on, highly visible and autonomous role. CRAs must have the ability to be flexible and represent LumaBridge in a positive and professional manner while collaborating across all levels with the clinical teams and Sponsors/vendors.

Location:

This is a remote-based position. Occasional Site travel (<50% and subject to business needs). LumaBridge cannot guarantee the location of sites, and CRAs should expect travel anywhere in the continental United States.

Responsibilities:

Perform site selection, initiation, monitoring, and close-out visits of investigational sites for the LumaBridge portfolio of clinical trials.
Manage the progress of assigned sites by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, data collection, and data query generation and resolution.
Conduct monitoring activities, including, but not limited to the following:
- Ensuring PI oversight of all trial activities
- Source data review and verification with EDC fields
- Essential documentation review and reconciliation
- Investigational Product (IP) management and accountability
- Lab/Kit supply management
Develop collaborative relationships with investigative sites and personnel.
Maintain communication with sites through frequent contact to ensure site compliance, adequate enrollment, and understanding of study requirements.
Write and submit complete and accurate visit letters and reports of investigational site findings and update applicable CTMS.
Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
Participate in audit preparations and follow-up, as needed.
Review and address protocol deviations, data quality issues, and identify process improvements for assigned sites.
Be a collaborative member of the study team: provide insight, updates, and strategies to improve processes.
Think critically while prioritizing tasks in an efficient manner to meet study deliverables.
Contribute to CRF development and perform User Access Testing, as requested.
Assist with other duties as assigned.

Qualifications:

Bachelor’s degree in life science/biomedical/medical science with a proficient knowledge of the clinical/scientific terminology and methods common to the oncology therapeutic setting.
2+ years of clinical research experience is required.
2+ years of experience at a CRO or Sponsor required.
Independent field monitoring experience of oncology clinical trials is required.
Early phase oncology experience is preferred.
Established track record of building key productive relationships with study investigators, site staff and internal study team personnel.
Proficient knowledge and practical utilization of ICH- GCP and applicable regulatory requirements.
Strong communication (written and verbal) and interpersonal skills.
Demonstrate effective presentation skills by clearly explaining complex concepts to a broad range of audiences.
Ability to independently prioritize tasks with excellent time management skills.
Highly proficient in computer applications, including Microsoft suite of applications, EDC, and CTMS applications.
Fluent in English (written and verbal).
Ability and willingness to travel as required (<50%), to include possession of the appropriate qualifications per independent sites regulations (to include but not limited to vaccinations).

APPLY NOW

The Medical Writer (MW)/Senior Medical Writer (SrMW) researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. He/She writes clear and concise documents, including clinical study reports, protocols, investigator brochures, summary documents, safety narratives, and other scientific and/or regulatory documents. The MW/SrMW drives medical writing deliverables and timelines with cross-functional team members and stakeholders. He/She may also be responsible for coordination of medical writing deliverables utilizing other contract medical writers or 3^rd party medical writing agencies. The MW/SrMW Writer will author and/or update Standard Operating Procedures (SOPs) or Work Instructions (WIs) for the Medical Writing function or related areas at LumaBridge.

Reports To:

VP Regulatory Affairs and Quality Assurance or designee

Title(s)

Medical Writer (MW), Senior Medical Writer (SrMW)

Location:

This is a remote-based position.

Responsibilities:

Provides expertise including organization, content, timelines, and resource requirements for medical writing activities at LumaBridge.
Serves as lead writer for clinical documents and/or key components of clinical regulatory submissions or response documents including but not limited to:
- Clinical study protocols and protocol amendments
- Investigator brochures
- Interim and final clinical study reports, including compilation and linking of appendices
- Informed Consent Forms (ICFs)
- Safety Narratives
- Other clinical documents including manuals, training guidelines or similar documents
- Clinical sections of IND or IDE or other regulatory submissions (IND annual reports, Development Safety Update Reports [DSURs], NDA or BLA submissions, etc.)
- Presentation materials, abstracts, publications.
Collaborates with clinical biometrics (including clinical data management and biostatistics), clinical operations, regulatory affairs, and medical monitors on the development or revision of the documents listed above.
Manages all aspects of the medical writing processes for document development including quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control and coordinating final reviews and approval.
Provides thorough document review and substantive editing of contributions, and ensures resolution of issues/comments.
Owns responsibility for all background preparation, literature searches, preparation of tables and extraction of data to complete tables and graphs, etc.
Manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content and adherence to regulatory requirements and processes.
Leads working group meetings and collaborates with authors to advance the development of documents/manuscripts/abstracts/posters/presentations.
Leads mock-up development of data displays (e.g., tables and figures); Reviews and interprets data and source documents for information required for document development.
Represents Medical Writing on cross-functional project teams.
Liaises with the regulatory department to ensure that documents to be submitted to a regulatory agency are eCTD compliant.
Stays current with updates to US and international regulations, requirements and guidance associated with medical writing and clinical regulatory document preparation and submissions.
Understands, assimilates and productively interprets sources of information (statistical and clinical data with appropriate guidance/direction from product teams and/or authors and management.
Provides financial stewardship by developing assumptions for budget templates and proposals and identifying/communicating out of scope activities.
Knowledge of Adobe Tools or other publishing software a plus.
Other duties as assigned.
Senior Medical Writer:

Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
Mentor junior or entry-level medical writers.
Coordinates/manages the activities of contract employees and vendors providing medical writing services to LumaBridge.

Qualifications:

Bachelor’s degree in science, health profession, English or journalism required. Pharm D or other advanced scientific degree preferred.
At least 3 years of oncology medical writing experience at a CRO, pharma or biotech.
Knowledge of US regulations, requirements and guidance associated with clinical regulatory document preparation.
Knowledge of GCP and good documentation practice.
Experience as a contributing writer for key documents included in major US and/or international regulatory submissions.
Exhibits excellent written and oral communication and presentation skills.
Familiarity in the use of medical writing templates and use of reference manager (or similar), PleaseReview, or other relevant software.
Excellent time and project management skills, team working skills, ability to meet deadlines and be results-oriented.
Ability to manage critical issues on multiple projects simultaneously.
Demonstrates the qualities of being highly organized, self-motivated, extremely detail-oriented, and a team player.
Senior Medical Writer:

5 or more years of oncology medical writing experience at a CRO, pharma or biotech; or one of more years of outstanding performance as a MW at LumaBridge.
Experience as the lead writer for key documents included in a major US and/or international regulatory submission.
Experience managing timelines and resources (including contractors and/or vendors) for medical writing activities preferred.

APPLY NOW

We will use the information provided in this form to consider your application and to contact you regarding any further steps in the application process. We will never share or sell your information. View our Privacy Policy.

LumaBridge is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status.

Apply Now

To apply, complete the form below. If you prefer to submit your application via direct email, please identify which position you are interested in and provide your contact information and resume to HRApplicants@lumabridge.com.

Cookie	Duration	Description
cookielawinfo-checkbox-analytics	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional	11 months	The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance	11 months	This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy	11 months	The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.