The Clinical Trials Manager (CTM) is responsible for leading the execution of clinical studies on schedule and on budget. CTM levels reflect the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in their Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule (Must be in the Waltham 3 days per week, will relocate a candidate to the area if interested but MUST be in the office 3 days a week). Responsibilities <ul> <li>Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.</li> <li>Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.</li> <li>Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.</li> <li>Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.</li> <li>Project leadership of the cross-functional study team, including external team members, CROs and vendors.</li> <li>Plan, negotiate, and manage site budgets as well as facilitate site contracting process.</li> <li>Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.</li> <li>May provide technical advice to team members.</li> <li>Disseminate clinical program communications to all functional groups and leads program, study and team meetings.</li> <li>Interact with clinical research investigators, Key Opinion Leaders and sites.</li> <li>Interact with Senior Management to report on progress of milestones.</li> <li>Oversight of study team and site training</li> <li>Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)</li> <li>Management of study drug distribution and accountability processes and documentation</li> <li>Oversight of study start-up, study management, data cleaning, and study closeout activities</li> <li>Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival</li> <li>Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.</li> </ul> Requirements <ul> <li>BA/BS degree in Health or Life Sciences required, advanced degree preferred</li> <li>A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role</li> <li>Exceptional communication and interpersonal skills</li> <li>Positive collaborative attitude</li> <li>Must speak fluent English if it is their second language</li> <li>Advanced proficiency in Microsoft Office and Microsoft Project</li> <li>Reliable, self-motivated, team player</li> <li>Detail oriented with excellent organizational skills</li> <li>Ability to effectively manage multiple tasks and competing priorities</li> <li>Creative problem solver</li> </ul> <img src="https://www.jobg8.com/Tracking.aspx?jJlm2RzFL%2fy8yttMoRskogd" width="0" height="0" />

The Clinical Trials Manager leads and executes clinical studies, ensuring timely, budget-compliant completion while adhering to SOPs, regulations, and ICH/GCP guidelines. Responsibilities include project leadership, vendor management, site budgeting, and quality assurance. The role involves developing contingency plans, managing study documentation, and providing mentorship in protocol development.

**Clinical Trials Manager**

**Location:** Waltham, MA

**Job Description:**

- Accountable for project related efforts for the delivery of studies or programs critical to a product's clinical development, ensuring completion on time, within budget, and in compliance with SOPs, regulations, and ICH/GCP guidelines.
- Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.
- Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
- Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
- Project leadership of the cross-functional study team, including external team members, CROs, and vendors.
- Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
- Develop and implement robust contingency and issue management plans to solve complex issues impacting study or program milestones.
- May provide technical advice to team members.
- Disseminate clinical program communications to all functional groups and lead program, study, and team meetings.
- Interact with clinical research investigators, Key Opinion Leaders, and sites.
- Interact with Senior Management to report on progress of milestones.
- Oversight of study team and site training.
- Facilitation of Quality processes and Quality Assurance interactions for assigned project(s).
- Management of study drug distribution and accountability processes and documentation.
- Oversight of study start-up, study management, data cleaning, and study closeout activities.
- Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.
- Provides mentorship, review, assistance, or leadership for the development and writing of study protocols, study plans, CRFs, and informed consent forms.

**Requirements:**

- BA/BS degree in Health or Life Sciences required, advanced degree preferred.
- A minimum 5+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role.
- Exceptional communication and interpersonal skills.
- Positive collaborative attitude.
- Must speak fluent English if it is their second language.
- Advanced proficiency in Microsoft Office and Microsoft Project.
- Reliable, self-motivated, team player.
- Detail oriented with excellent organizational skills.
- Ability to effectively manage multiple tasks and competing priorities.
- Creative problem solver.

Clinical Trial Manager

ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs. This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH) Responsibilities (including, but not limited to): <ul> <li> Drive and lead the development of all databases and eCRF design </li> <li> Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines </li> <li> Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies </li> <li> Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes </li> <li> Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans </li> <li> Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each </li> <li> Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning </li> <li> Review, track, and report status of all data management project(s) to senior leadership </li> <li> Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation </li> <li> Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) </li> <li> Partner with cross functional key stake holders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors </li> <li> Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development </li> <li> Uphold a reputation for data integrity and compliance </li> </ul> Requirements <ul> <li> Requires a Bachelors degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization </li> <li> Extensive knowledge and experience in clinical data management </li> <li> Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards </li> <li> Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans </li> <li> Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG) </li> <li> Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations </li> <li> Demonstrated experience in managing multiple CROs/vendors </li> <li> Demonstrated strong written and verbal communication skills </li> <li> Proven mindset of proactive continuous improvement </li> <li> Efficient independent worker with ability to focus and drive for results </li> <li> Strong attention to detail </li> <li> Ability to work in a fast paced-environment and to handle multiple tasks </li> <li> Strong commitment to ethical standards </li> <li>

The Associate Director of Clinical Data Management is responsible for defining and leading the clinical data management strategy, overseeing start-up and execution of complex trials, and ensuring data quality and compliance. They will manage vendor relationships, develop databases and eCRF designs, implement data validation measures, and maintain data integrity. This role involves coordinating with cross-functional teams, managing clinical trial data queries, and contributing to SOP development. A scientific degree and extensive experience in clinical data management are required.

**Associate Director Clinical Data Management**

**Location:** Waltham, MA

Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. The Associate Director, Clinical Data Management is responsible for overseeing the start-up and execution of multiple, complex trials with a CRO and supporting upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.

This role is based in our Waltham, MA headquarters. Our office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH).

**Job Description:**

- Drive and lead the development of all databases and eCRF design
- Plan, develop and implement UAT (user acceptance testing), data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines
- Develop and execute data validation guidelines and measures to ensure accurate data gathering from clinical studies
- Review and provide expertise on all eCRF changes, respond accordingly to make resulting database changes
- Organize and direct the initial stage of the studies, review and sign off on various items such as eCRF, data validation, data review guidelines, and data management plans
- Oversee and build strong sustainable relationships with multiple global CROs/vendors along with managing the process and coordination of each
- Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning
- Review, track, and report status of all data management project(s) to senior leadership
- Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation
- Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)
- Partner with cross functional key stakeholders to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting; Serve as internal expert on data management with vendors
- Develop data management SOPs and processes that align and address business priorities; Contribute to cross-functional SOP development
- Uphold a reputation for data integrity and compliance

**Requirements:**

- Requires a Bachelor's degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization
- Extensive knowledge and experience in clinical data management
- Direct experience with different Data Management systems and technologies, Electronic Data Capture systems and CDISC data standards
- Extensive knowledge reviewing study planning documents such as Edit Check Specs, UAT scripts, Data Management Plans
- Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)
- Deep understanding of drug development, study conduct processes, GCP and regulations related clinical data management as well as ICH guidelines, FDA/EU regulations
- Demonstrated experience in managing multiple CROs/vendors
- Demonstrated strong written and verbal communication skills
- Proven mindset of proactive continuous improvement
- Efficient independent worker with ability to focus and drive for results
- Strong attention to detail
- Ability to work in a fast paced-environment and to handle multiple tasks
- Strong commitment to ethical standards

Associate Director, Clinical Data

Contract Remote Medical Director Title: Medical Director/Senior Medical Director, Clinical Development Reports to: Head of Neuroscience Therapeutic Area, Clinical Development Position Overview: The Medical Director will support one or more development programs involving drug candidates in neuroscience. This role will focus on crafting and executing clinical trials in clinical development and work as a medical monitor for one or more studies. The Medical Director will be responsible for designing and executing development strategies as well as interpreting data from clinical studies. Responsibilities: Serve as the primary medical point of contact for a project or study Lead medical monitoring while effectively performing and managing medical and safety reviews, processes, and projects for assigned compound development programs and clinical studies Contribute to the design, planning, and medical oversight of clinical trials for neurodegenerative disorders and provide clear and insightful clinical and scientific expertise to facilitate transition of assets from early clinical phase to late phase development Partner with Clinical Operations on the initiation and conduct of clinical trials, while interacting closely with other relevant functional areas in the preparation of clinical development plans, protocols, investigator brochures, clinical study reports, manuscripts and scientific presentations Interact in a proactive manner with CROs and other service providers to enhance communication between company and third parties, including guidance to assess patient eligibility and ongoing protocol management Build and maintain collaborative relationships with investigators, thought leaders and sites across targeted disease area Requirements: Education and Experience: Medical Degree (MD) required Neurologist preferred Board eligible or board certified with current medical license in US preferred 2+ years experience in clinical development and medical monitoring in biotech/pharmaceuticals 5+ years in clinical practice with experience in neurodegenerative diseases Proven experience working with clinical trials as an investigator/co-investigator Ability to understand complex scientific, clinical, biomarker-based, and statistical data and issues from an analytical standpoint Domestic and International travel as required Competencies and Attributes: Demonstrated leadership to drive results that are needed to achieve company objectives in accord with companys culture and values courageous, imaginative, selfless and joyful Excellent understanding of the clinical /pharmaceutical process to effectively communicate and provide required deliverables Exceptional leadership and team-building skills <img src="https://www.jobg8.com/Tracking.aspx?1CKwo8KuDwDyF8TRBjBbiQi" width="0" height="0" />

The Medical Director will support neuroscience drug development programs, focusing on clinical trial design and execution. Responsibilities include serving as the primary medical contact, leading medical monitoring, and collaborating with clinical operations. The role involves designing development strategies, interpreting clinical study data, and maintaining relationships with investigators and thought leaders. The candidate must have a medical degree, preferably be a neurologist, with experience in clinical development and neurodegenerative diseases. Leadership, teamwork, and communication skills are essential to drive results aligned with company values.

**Medical Director/Senior Medical Director, Clinical Development**

**Job Description:**

- Support one or more development programs involving drug candidates in neuroscience.
- Craft and execute clinical trials in clinical development.
- Act as a medical monitor for one or more studies.
- Responsible for designing and executing development strategies as well as interpreting data from clinical studies.

**Responsibilities:**

- Serve as the primary medical point of contact for a project or study.
- Lead medical monitoring and manage medical and safety reviews, processes, and projects for assigned compound development programs and clinical studies.
- Contribute to the design, planning, and medical oversight of clinical trials for neurodegenerative disorders.
- Provide clear and insightful clinical and scientific expertise to facilitate the transition of assets from early clinical phase to late phase development.
- Partner with Clinical Operations on the initiation and conduct of clinical trials.
- Interact closely with other relevant functional areas in the preparation of clinical development plans, protocols, investigator brochures, clinical study reports, manuscripts, and scientific presentations.
- Interact proactively with CROs and other service providers to enhance communication between company and third parties.
- Provide guidance to assess patient eligibility and ongoing protocol management.
- Build and maintain collaborative relationships with investigators, thought leaders, and sites across targeted disease areas.

**Requirements:**

- Medical Degree (MD) required; Neurologist preferred.
- Board eligible or board certified with current medical license in the US preferred.
- 2+ years experience in clinical development and medical monitoring in biotech/pharmaceuticals.
- 5+ years in clinical practice with experience in neurodegenerative diseases.
- Proven experience working with clinical trials as an investigator/co-investigator.
- Ability to understand complex scientific, clinical, biomarker-based, and statistical data and issues from an analytical standpoint.
- Domestic and International travel as required.

**Competencies and Attributes:**

- Demonstrated leadership to drive results needed to achieve company objectives in accordance with company's culture and values: courageous, imaginative, selfless, and joyful.
- Excellent understanding of the clinical/pharmaceutical process to effectively communicate and provide required deliverables.
- Exceptional leadership and team-building skills.

Medical Director, Clinical Development

Senior Clinical Trial Manager Description Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget. The Senior Clinical Trial Manager ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the companys strategic goals. The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects or programs. This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. Responsibilities (including, but not limited to): <ul> <li>Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.</li> <li>Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.</li> <li>Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.</li> <li>Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines. </li> <li>Project leadership of the cross-functional study team, including external team members, CROs and vendors.</li> <li>Plan, negotiate, and manage site budgets as well as facilitate site contracting process. </li> <li>Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones. </li> <li>May provide technical advice to team members. </li> <li>Disseminate clinical program communications to all functional groups and leads program, study and team meetings. </li> <li>Interact with clinical research investigators, Key Opinion Leaders and sites. </li> <li>Interact with Senior Management to report on progress of milestones. </li> <li>Oversight of study team and site training </li> <li>Facilitation of Quality processes and Quality Assurance interactions for assigned project(s) </li> <li>Management of study drug distribution and accountability processes and documentation </li> <li>Oversight of study start-up, study management, data cleaning, and study closeout activities </li> <li>Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival </li> <li>Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.</li> </ul> Requirements <ul> <li>BA/BS degree in Health or Life Sciences required, advanced degree preferred </li> <li>A minimum 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role </li> <li>Exceptional communication and interpersonal skills</li> <li>Positive team orientated attitude </li> <li>Must speak fluent English if it is their second language</li> <li>Advanced proficiency in Microsoft Office and Microsoft Project </li> <li>Reliable, self-motivated, team player </li> <li>Detail oriented with excellent organizational skills </li> <li>Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment</li> <li>Creative problem solver </li> <li>Strong commitment to ethical standards</li> <li>Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)</li> <li>Ability to travel as needed </li> <li>The salary range for this position is commensurate with experience</li> </ul> <img src="https://www.jobg8.com/Tracking.aspx?oHs1Nm8oTt8Vr%2fYBhQuTLAd" width="0" height="0" />

The Senior Clinical Trial Manager leads the execution of clinical studies, ensuring projects are completed on time and within budget. Responsibilities include developing timelines, managing vendors, providing leadership to cross-functional teams, and facilitating quality assurance. The role requires strong communication, problem-solving skills, and a commitment to ethical standards.

**Senior Clinical Trial Manager**

**Location:** Waltham, MA

**Job Description:**

- Reporting to the Director, Clinical Operations, the Senior Clinical Trial Manager is responsible for leading the execution of clinical studies on schedule and on budget.
- Ensures studies are conducted efficiently and with quality, adhering to timelines and budget, and in alignment with the company's strategic goals.
- The level reflects the experience, skill level, and capacity to manage larger and/or more complex studies, projects, or programs.
- Office-based employees are required to work in the office three (3) days a week.

**Responsibilities:**

- Accountable for project-related efforts for the delivery of studies or programs that are critical to a product's clinical development, ensuring that they are completed on time, within budget, and in compliance with SOPs, regulations, and ICH/GCP guidelines.
- Supports external vendor selection and management process and assists in the development of RFPs and vendor oversight plans.
- Provide clinical leadership to CROs, other vendors, CRA team, and CTAs.
- Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines.
- Project leadership of the cross-functional study team, including external team members, CROs, and vendors.
- Plan, negotiate, and manage site budgets as well as facilitate site contracting process.
- Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones.
- May provide technical advice to team members.
- Disseminate clinical program communications to all functional groups and leads program, study, and team meetings.
- Interact with clinical research investigators, Key Opinion Leaders, and sites.
- Interact with Senior Management to report on the progress of milestones.
- Oversight of study team and site training.
- Facilitation of Quality processes and Quality Assurance interactions for assigned project(s).
- Management of study drug distribution and accountability processes and documentation.
- Oversight of study start-up, study management, data cleaning, and study closeout activities.
- Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival.
- Provides mentorship, review, assistance, or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms.

**Requirements:**

- BA/BS degree in Health or Life Sciences required, advanced degree preferred.
- A minimum of 8+ years of experience or demonstration of equivalent capability in a Clinical Trials Manager role.
- Exceptional communication and interpersonal skills.
- Positive team-oriented attitude.
- Must speak fluent English if it is their second language.
- Advanced proficiency in Microsoft Office and Microsoft Project.
- Reliable, self-motivated, team player.
- Detail-oriented with excellent organizational skills.
- Ability to effectively manage multiple tasks and competing priorities in a fast-paced environment.
- Creative problem solver.
- Strong commitment to ethical standards.
- Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.).
- Ability to travel as needed.

Clinical Dynamix, Inc. Jobs