CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Associate Director, Clinical Operations

Company: Nomis Solutions
Location: Cambridge
Posted on: September 15, 2020

Job Description:

The Associate Director is accountable for the oversight of a full development program and their direct reports on the Clinical Operations team. They are well versed in knowledge of operational methodologies, clinical research, ICH/GCP Guidelines, program management and delegation to/oversight of Clinical Trial Managers. They are responsible for the development of the clinical timelines, and are the co-author of the individual study timelines/deliverables/milestones

Duties and Responsibilities:

Have the skillset and experience to manage (or oversee the execution of) all related study start up, maintenance and close out activities

Create and maintain Program Budget forecast and execution, including a Clinical Development Plan, with program oversight of all aspects of the clinical development budgets of all studies within their program

Responsible for the clinical operations program development, the related clinical timelines and study timelines/deliverables/milestones

Have experience with and the ability to prioritize day to day issues and overarching goals with a keen eye to (understanding of) ICH/GCP Guidelines, escalating to Upper Management as appropriate

Assist with RFP generation, vendor selection, review of SOWs and Change Orders, as well as acting as a point of escalation for vendors within their clinical program

Contribute to and assist in maintaining a quality-focused clinical infrastructure by assisting in development, revision and/or implementation of SOPs consistent with the organization’s day to day execution of trials such that operational processes, systems and standards are consistent with GXP and are adopted, implemented and documented consistently across trials and programs

Maintain direct reports, regular meetings and oversight as well as complete all yearly review activities; Review and sign off on direct report’s documents

Train and mentor junior staff on Clinical Operations processes and the related execution of GCP and ICH guidelines such that compliance is the top priority, followed closely by excellent execution of all responsibilities

Lead process improvement initiatives, helping to maintain best practices and lessons learned across programs

Qualifications:

Bachelor’s Degree in a related field with at least eight years’ experience in the biotech and/or pharmaceutical industries, with at least seven years in clinical operations

Global clinical trial/Program Management and Phase I experience are both necessary, as is experience in Oncology and/or Rare Disease development

Track record of effective management of multiple projects/priorities and budgets in early to late phase development

Thorough understanding of GCP/ICH Guidelines, global regulatory requirements and strategic implications for downstream clinical development

Extensive vendor oversight and management experience, including negotiations and contract execution

Excellent interpersonal and communications skills (verbal and written), as well as problem solving skills

Demonstration of strong management abilities and mentoring skills, with prior experience managing, mentoring and training Clinical Operations staff

Ability and willingness to travel up to 20% (domestic and international)

U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Beam Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary . Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status Please select Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability Why are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

Autism

Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS

Blind or low vision

Cancer

Cardiovascular or heart disease

Celiac disease

Cerebral palsy

Deaf or hard of hearing

Depression or anxiety

Diabetes

Epilepsy

Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome

Intellectual disability

Missing limbs or partially missing limbs

Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)

Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Nomis Solutions, Cambridge , Associate Director, Clinical Operations, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Part - Time Warehouse Operator - $15.25 - $18.25/hr
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Full-time Warehouse Worker - $500 sign-on bonus
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 16.75/hr, plus benefits and a 500 sign-on bonus. Limited Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Warehouse Handler (Full-Time) - With $500 Sign-on Bonus
Description: Full-time Warehouse Team Member - 500 sign-on bonus br br Hourly pay rate: br Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. br Limited-Time Opportunity br br Location: (more...)
Company: Amazon
Location: East Providence
Posted on: 09/25/2020


UH-60 Utility Helicopter Repairer
Description: The UH-60 Black Hawk helicopter is the best-in-class, multi-mission performer used for combat assault, search and rescue, medevac, and firefighting missions. Your responsibility as the UH-60 Utility (more...)
Company: Army National Guard
Location: Concord
Posted on: 09/25/2020

Licensed Life Insurance Independent Contractor - Work from Home
Description: Licensed Life Insurance Independent Contractor - Work from Home br br br br We got what you want, you got what we need br br br br Are you a Licensed Insurance Agent looking for a flexible (more...)
Company: LiveOps
Location: East Providence
Posted on: 09/25/2020

Amazon Order Picker/Packer
Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation Fall River, MAJob opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Amazon Workforce Staffing Amazon Pickerpacker Immediate Hire
Description: Amazon Workforce Staffing Amazon Pickerpacker Immediate Hire - Amazon Workforce StaffingWarehouse Team Member Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)
Company: Cylcon Jobs
Location: East Providence
Posted on: 09/25/2020

Amazon Order Picker/Packer
Description: br br Warehouse Team Member Part-Time, Full-Time, Flexible Hours br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br Fall River, MA br Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Remote Licensed Life Insurance Independent Contractor
Description: Licensed Life Insurance Independent Contractor - Work from Home br br We got what you want, you got what we need br br Are you a Licensed Insurance Agent looking for a flexible opportunity One (more...)
Company: LiveOps
Location: East Providence
Posted on: 09/25/2020

Sort Center - Part-Time Up to $18/hr
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds