Top 144 Clinical research manager Jobs in Middleton, Ma

Principal Clinical Trial Manager
TransMedics, Inc. —Andover, MA
- $137,100 - $193,700 a year
- Full-time
- Bachelor of Science
- Office
- Master's degree
- Employee stock purchase plan
- Disability insurance
Quick Apply
Clinical Research Manager - Breast Oncology Clinical Trials
Dana-Farber Cancer Institute —Boston, MA
- $77,400 - $102,800 a year
- Full-time
- Hybrid work
- Analysis skills
- Bachelor's degree
- Recruiting
Program Manager Clinical, Translational Research Institute
Boston University —Boston, MA
- Mid-level
- Administrative experience
- Bachelor's degree
9d
Research Project Manager, Geriatrics
Boston University —Boston, MA
- Management
- Mid-level
- Master's degree
Senior Project Manager, Clinical Operations
Bicara Therapeutics —Boston, MA
- $176,000 - $206,000 a year
- Full-time
- Remote
- 5 years
- Analysis skills
- Bachelor's degree
Clinical Trial Manager
Seaport Therapeutics —Boston, MA
- $133,000 - $150,000 a year
- Bachelor of Science
- Office
- Bachelor's degree
Senior Clinical Trial Manager
Entrada Therapeutics —Boston, MA
- $160,000 - $185,000 a year
- Remote
- 7 years
- Bachelor of Science
- Bachelor's degree
- Disability insurance
- Health insurance
Quick Apply
Clinical Research Manager
RevBio, Inc. —Lowell, MA
- Full-time
- Hybrid work
- 5 years
- Engineering
- Public speaking
- Work from home
Quick Apply
Clinical Research Center Manager
Joslin Diabetes Center —Boston, MA
- $117,260 - $158,496 a year
- Full-time
- Nursing
- Clinic
- Analysis skills
- Disability insurance
- Health insurance
Clinical Research Manager
Tufts University —Boston, MA
- $74,000 - $111,000 a year
- Hybrid work
- Nursing
- 5 years
- HIPAA
Senior Clinical Trial Manager
Bicara Therapeutics —Boston, MA
- $176,000 - $197,000 a year
- Full-time
- Hybrid work
- Nursing
- 5 years
- Computer literacy
Region Manager
Care Access —Boston, MA
- $95,000 - $115,000 a year
- Up to 50% travel
- Inventory management
- Pass drug screening
- Health savings account
- Paid holidays
Research Project Manager
VA Boston Healthcare System —Boston, MA
- $84,579 - $109,959 a year
- Full-time
- Background check
- Microsoft Excel
- HIPAA
- Health savings account
- Health insurance
Quick Apply
Senior Manager, Clinical Partner Outsourcing
Takeda Pharmaceutical —Boston, MA
- $137,000 - $215,270 a year
- Full-time
- Hybrid work
- 7 years
- CPA
- Bachelor's degree
- Paid holidays
- Disability insurance
3d
Lead Clinical Study Manager (Lead CSM)
Takeda Pharmaceutical —Boston, MA
- $116,000 - $182,270 a year
- Full-time
- Remote
- 6 years
- Doctoral degree
- Bachelor of Science
- Paid holidays
- Disability insurance
Clinical Trial Manager/Senior Clinical Trial Manager
Oruka Therapeutics —Waltham, MA
- $146,000 - $187,000 a year
- Hybrid work
- 5 years
- Office
- Master's degree
Clinical Operations Manager
Tessera Therapeutics —Somerville, MA
- $164,000 - $199,000 a year
- Microsoft Word
- Microsoft Excel
- 8 years
- Disability insurance
- Health insurance
Manager, External Communications (Research)
Boston Children's Hospital —Boston, MA
- $105,102.40 - $168,157.60 a year
- Full-time
- 5 years
- Office
- Master's degree
1d
Clinical Trials Manager
Tango Therapeutics —Boston, MA
- $120,000 - $180,000 a year
- Hybrid work
- 5 years
- Analysis skills
- Bachelor's degree
6d
Program Manager, Research
Beth Israel Lahey Health —Boston, MA
- $65,000.00 - $119,995.20 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Hospital

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Principal Clinical Trial Manager

TransMedics, Inc. -
Andover, MA

Quick Apply

Job Details

Full-time
$137,100 - $193,700 a year

Benefits

Employee stock purchase plan
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
Pet insurance

Qualifications

Bachelor's degree
Pharmaceutical company experience
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
IRB compliance
Ethical review application preparation

Full Job Description

Job Description:

POSITION SUMMARY

The Principal Clinical Trial Manager provide leadership in the development of clinical trial activities and ensure that clinical trials are completed in time and with the highest quality with thoughtful delegation of study related tasks and assignments.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

Leading the process of pre and post market clinical trials for FDA by employing effective organizational strategies and reviewing and presenting the results using rigorous clinical procedures
Responsible for creating study specific templates across all programs
Responsible for managing the planning, implementation, and tracking of the clinical monitoring process with CRAs
Provide oversight of drafting all annual and bi-annual pre and post market reports to FDA in collaboration with the regulatory team
Lead all clinical site interactions (including assistance with IRB/EC applications, contract negotiations, enrollment tracking, clinical trial material and clinical supply requests, issue resolution, etc.)
Own and manage all trial start-up, conduct, and close-out activities according to industry and corporate standards
Lend expertise to the preparation of key clinical documents in conjunction with other team members (e.g. protocols, informed consent, amendments, CRF’s, training materials, project plans, monitoring plans, data plans, statistical analysis plans, summary reports, etc.)
Establish professional rapport and engage in frequent communication with investigational site personnel in order to keep study on-track
Track internal metrics, timelines and budgets
Communicate trial status to trial team
Prepare and present trial specific updates to management
Oversee and participate in monitoring activities at clinical trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, SOPs, protocols and take ownership for data completion and accuracy
Interact with data management personnel to plan, monitor, and execute data analyses
Support applications and technical files as needed
Collaborate with project specific committees (e.g., DSMB, CEC)
Assist with preparation for investigators’ meetings
Work with vendors as needed
Perform other TransMedics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

None (Standard office environment).
Travel up to 25% of the time

MINIMUM QUALIFICATIONS

BA/BS in Science, Life Sciences or relevant field
8-10 years’ pharmaceutical drug development, biotech or CRO industries experience monitoring and managing clinical trials (cardiovascular therapeutic indications preferred); or equivalent combination of education and experience. Proven expertise in executing IRB/EC submissions and approvals

PREFERRED QUALIFICATIONS

Masters in Science, Life Sciences or relevant field; or equivalent combination of education and experience
Experience in medical device (strongly preferred),
Outstanding track record leading large complex global clinical trials for medical device products in different phases of the product cycle
Broad and deep knowledge of device clinical trial documentation requirements including monitoring requirements, FDA regulations, and operational aspects of clinical trials
Experience complying with GCP, ICH, ISO and FDA regulatory requirements
Proven ability to identify operational issues and proactively recommend and implement strategies to resolve problems
In-depth knowledge of adverse event investigation, analysis, and reporting procedures and standards
Willing to be held accountable for deliverables
Must be highly organized and detail oriented
Experience interfacing with multiple vendors/contractors
Proven ability to handle multiple projects and changing priorities
Must be results-driven and exhibit a sense of urgency
Clear and concise in verbal and written communication, fosters smooth flow of timely and relevant information
Strong initiative and positive attitude
Ability to support and build collaborative relationships both internally and externally
Demonstrated ability to make timely decisions using sound judgment
Experience with electronic data capture (EDC)
Experience in clinical budget planning and management
Influential & assertive communication skills
Excellent leadership skills
Good record keeping skills
Ability to motivate
Self Confidence
Ability to think Out-of-the-box
Problem solving skills
Conflict management skills

Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.

Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.

Maximize your potential at TransMedics, Inc.
www.TransMedics.com

TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $137,100.00 – $193,700.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.

Employee Benefit:

Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending Account

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.

Quick Apply

Refine Your Search

clinical research manager jobs in middleton, ma

Principal Clinical Trial Manager

Clinical Research Manager - Breast Oncology Clinical Trials

Program Manager Clinical, Translational Research Institute

Research Project Manager, Geriatrics

Senior Project Manager, Clinical Operations

Clinical Trial Manager

Senior Clinical Trial Manager

Clinical Research Manager

Clinical Research Center Manager

Clinical Research Manager

Senior Clinical Trial Manager

Region Manager

Research Project Manager

Senior Manager, Clinical Partner Outsourcing

Lead Clinical Study Manager (Lead CSM)

Clinical Trial Manager/Senior Clinical Trial Manager

Clinical Operations Manager

Manager, External Communications (Research)

Clinical Trials Manager

Program Manager, Research

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