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The Clinical Trial Manager will be responsible for managing multiple multi-center, randomized controlled clinical studies in accordance with protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements, preferably including (but not required) 21CFR Part 1271/ 361 Human cells, Tissues, and Cellular and Tissue-Based Products (HCT/P).
This position will be responsible for the operational management, oversight, and successful execution of wound care clinical studies from protocol concept through the clinical study report and publication, while ensuring completion of study deliverables. Implement and manage clinical development plans and timelines that lead to timely implementation, execution, and analysis of clinical studies in preparation for regulatory submissions. Identify and manage the activities needed to achieve this goal utilizing internal and external resources. Establish good working relationships with internal legal, medical, clinical, manufacturing operations, regulatory, marketing, and health care economics teams. Prepare clinical documentation to support reimbursement necessities and marketing messages for post-market studies and regulatory submissions for investigational studies.
Proven ability to independently prioritize and manage multiple tasks and projects with competing priorities and deadlines, screen and prioritize communications and opportunities from external sources. S/he shall have and utilize technical knowledge and build clinical research capabilities, implementing appropriate procedures and policies. The ideal candidate will be dynamic, articulate, high-energy, organized, and able to support cross-functional coordination in a fast paced environment, assist with developing department staff; and manage consultants and Contract Research Organizations (CROs). S/he will develop and maintain relationships with Investigators and their study staff as well as key opinion leaders. Position is in-house and requires approximately 25-40% travel.
KEY RESPONSIBILITIES
Full Time
$129k-168k (estimate)
04/06/2023
06/01/2024
organogenesis.com
CANTON, MA
500 - 1,000
1985
Public
GARY S GILLHEENEY SR
$200M - $500M
Organogenesis is a Massachusetts-based regenerative medicine company that develops bioactive and acellular biomaterials products to treat orthopedics and spine diseases.
The job skills required for Clinical Trial Manager include Clinical Trial, Clinical Research, Initiative, SOP, Analysis, Coordination, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Trial Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Trial Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Trial Manager positions, which can be used as a reference in future career path planning. As a Clinical Trial Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Manager. You can explore the career advancement for a Clinical Trial Manager below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Trial Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Trial Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Clinical Trial Manager job description and responsibilities
Presented overall audit to clinical policy and oversight committee and departmental managers.
02/14/2022: Erie, PA
Before a medical treatment can be administered to the general population, a clinical trial manager needs to oversee a test study.
03/03/2022: Pine Bluff, AR
Clinical trial managers make sure all aspects of clinical trials meet regulatory requirements and scientific standards while protecting patient safety.
02/24/2022: Santa Ana, CA
Clinical Trial Managers are responsible for executing and supervising clinical trials using effective organizational strategies.
03/24/2022: Alamogordo, NM
Learn more about the requirements, responsibilities, training, salary, and job outlook of Virtual Clinical Trial Managers.
01/29/2022: Florence, SC
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Trial Manager jobs
Communication, feedback, and mentoring are part of a clinical trial manager's job.
02/21/2022: Riverside, CA
Clinical trial managers also hire, train, and evaluate the members of the clinical team.
01/23/2022: Flagstaff, AZ
Without a Clinical Trial Manager to select projects and balance speed with safety, Physicians would waste time researching low-demand medications while putting lifesaving medicines on hold.
04/05/2022: Battle Creek, MI
A clinical trial manager must also possess effective leadership abilities.
03/24/2022: Bangor, ME
Clinical Trial Managers must possess excellent communication skills, leadership ability and multitasking personality.
04/01/2022: Springfield, MA
Step 3: View the best colleges and universities for Clinical Trial Manager.