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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on– now and in the future.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screening

Discover Impactful Work:

Acts as a study manager for multiple studies individually or as a program of several studies. May perform the Project Manager role for standalone studies. Responsible for functional, administrative and financial oversight of assigned projects.

A day in the Life:

+ Provides support and coaching to the DM team to ensure that all tasks are Functions completed accurately, on time and within budget to meet or exceed client expectations.

+ Acts as a primary liaison for project team and client.

+ May develop and implement study specific training for DM project staff and performs independent reviews of DM deliverables following CDM guidelines.

+ Monitors, evaluates and proposes mitigation strategies surrounding risk to deliverables and finances.

+ Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. Additionally, promotes repeat business by developing relationships with new and existing clients.

+ Performs project forecasting of hours and identification of resource requirements and manages project budgets including identification of out of scope work and participate in the Contract Modification process.

+ Participates in the development and implementation of processes, procedures and training for the data management function as directed.

+ Mentors junior level staff and peers on all associated tasks within a study or program.

+ Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.

Keys to Success:

+ Bachelor's degree or equivalent and relevant formal academic / vocational qualification

+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Candidates **must have** direct experience in Clinical Data Management in a CRO, Pharmaceutical or Biotech environment.

+ In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

+ Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations

+ Ability to use interactive computer programs

+ Excellent written/ verbal communication skills with a strong command of English language and grammar; strong organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skills

+ Ability to identify project risks and to effectively evaluate and develop plans to mitigate those risks

+ Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

+ Ability to act as a study or department expert for DM processes.

+ Ability to train and direct a study team, providing leadership and direction to both subordinates and peers

+ Ability to forecast project resourcing, project timeline planning and adherence to timelines.

+ Ability to supervise and delegate tasks.

+ Ability to successfully apply above skills, knowledge and abilities across a portfolio of studies

Physical Requirements / Work Environment:

+ Work is performed in an office environment with exposure to electrical office equipment.

+ Occasional drives to site locations with occasional travel both domestic and international.

+ Frequently stationary for 6-8 hours per day.

+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

+ Frequent mobility required.

+ Occasional crouching, stooping, bending and twisting of upper body and neck.

+ Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

+ Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

+ Frequently interacts with others to obtain or relate information to diverse groups.

+ Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.

+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

+ Regular and consistent attendance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.